A Medical Research Study to Evaluate the Effects of ACT-2... | NCT03384966 | Trialant
NCT03384966
Sponsor
Viatris Innovation GmbH
Status
Completed
Last Update Posted
Jul 9, 2025Actual
Enrollment
346Actual
Phase
Phase 2
Conditions
Stable Coronary Artery Disease
Interventions
Selatogrel
Placebo
Selatogrel
Countries
United States
Canada
Denmark
Germany
Netherlands
Singapore
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03384966
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ID-076A201
Secondary IDs
ID
Type
Description
Link
2017-003332-36
EudraCT Number
Brief Title
A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease
Official Title
A Multi-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Pharmacodynamics, Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Injection of ACT-246475 in Adults With Stable Coronary Artery Disease
Acronym
Not provided
Organization
Viatris Inc.INDUSTRY
Status Module
Record Verification Date
Nov 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 24, 2018Actual
Primary Completion Date
Aug 18, 2018Actual
Completion Date
Sep 18, 2018Actual
First Submitted Date
Dec 20, 2017
First Submission Date that Met QC Criteria
Dec 20, 2017
First Posted Date
Dec 28, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Apr 23, 2021
Results First Submitted that Met QC Criteria
Apr 23, 2021
Results First Posted Date
May 17, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 11, 2019
Certification/Extension First Submitted that Passed QC Review
Jul 11, 2019
Certification/Extension First Posted Date
Jul 17, 2019Actual
Last Update Submitted Date
Jun 30, 2025
Last Update Posted Date
Jul 9, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Viatris Innovation GmbHINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The goal of this study is to find out if a drug called selatogrel (ACT-246475) can prevent platelets from binding together when administered by an injection under the skin in the thigh or in the belly. Another goal is to know how fast and for how long selatogrel (ACT-246475) works and if there is a difference if the drug is injected in the thigh or in the belly. This study will also help to find out more about the safety of this new drug.
Detailed Description
To investigate the pharmacodynamic (PD) and pharmacokinetic (PK) properties of selatogrel in patients with atherosclerotic disease, the present study will be conducted in patients with chronic coronary syndromes (CCS). Assessment in a population of patients with CCS allows better control and stability of concomitant treatments, and therefore more accurate characterization of the pharmacodynamic and pharmacokinetic profiles of selatogrel in the presence of background antiplatelet therapies.
The study will have 3 periods: a screening period of up to 21 days prior to randomization, a treatment period of 2 days from randomization (Day 1) to 24 hours post dose (Day 2), and a follow-up period from Day 3 to the safety follow-up telephone call 28 to 35 days after single administration of study drug (End-of-Study).
Conditions Module
Conditions
Stable Coronary Artery Disease
Keywords
Chronic coronary syndrome
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
346Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Selatogrel 8 mg
Experimental
Selatogrel (ACT-246475) is given as a single subcutaneous dose of 8 mg administered in a volume of 0.8 mL. Administration will be performed at the investigational site by qualified personnel.
Drug: Selatogrel
Selatogrel 16 mg
Experimental
Selatogrel (ACT-246475) is given as a single subcutaneous dose of 16 mg administered in a volume of 0.8 mL. Administration will be performed at the investigational site by qualified personnel.
Drug: Selatogrel
Placebo
Placebo Comparator
Placebo matching ACT-246475 is supplied in sealed glass vials for reconstitution with water for injection. Placebo will be given as a single subcutaneous dose matching selatogrel to be administered in a volume of 0.8 mL. Administration will performed at the investigational site by qualified personnel.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Selatogrel
Drug
Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) or matching placebo will be reconstituted with 1 mL of water for injection. Further dilution with 1 mL sodium chloride (NaCl) 0.9% will be performed for preparation of the dose of 8 mg selatogrel.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU of less than 100 starting from 30 minutes after the administration of study treatment and lasting for at least 3 hours was considered a "responder".
From 15 minutes after administration of the subcutaneous injection up to 24 hours
Secondary Outcomes
Measure
Description
Time Frame
Maximum Selatogrel Plasma Concentration (Cmax)
The Cmax is the peak concentration of selatogrel in the plasma after subcutaneous injection.
The pharmacokinetic parameters of selatogrel (ACT-246475) were derived by non-compartmental analyses of the plasma concentration-time profiles.
Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours
Other Outcomes
Measure
Description
Time Frame
Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation by Site of Treatment Administration (Thigh or Abdomen)
The inhibition of platelet aggregation based on the route of administration, i.e. whether the pharmacodynamic response was different if selatogrel was administered subcutaneously in the thigh or in the abdomen, was analyzed.
The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU of less than 100 starting from 30 minutes after the administration of study treatment and lasting for at least 3 hours was considered a "responder".
Eligibility Module
Eligibility Criteria
Main Inclusion Criteria:
Signed informed consent prior to any study-mandated procedure.
Male and female subjects aged from 18-85 years, inclusive.
For women of childbearing potential: Negative urine pregnancy test at Visit 1 and at Visit 2 before randomization.
Stable Coronary artery disease (CAD) defined by the presence of any of the following conditions:
History of CAD with coronary artery stenosis on coronary angiogram ≥50%.
Previously documented myocardial infarction occurring more than 3 months prior to randomization.
Antiplatelet background therapy stable for at least 1 month prior to randomization.
Body weight ≥ 40.0 kg (88.2 lbs).
Main Exclusion Criteria:
Acute coronary syndrome, percutaneous coronary intervention or any intervention for peripheral artery disease within 3 months prior to randomization.
Acute ischemic stroke or transient ischemic attack (TIA) within 3 months prior to randomization.
Active internal bleeding, or medical history of recent (< 1 month) bleeding disorders or conditions associated with high risk of bleeding (e.g., clotting disturbances, gastrointestinal bleed, hemoptysis).
Hemoglobin ≤ 10 g/dL at screening.
Loss of at least 250 mL of blood within 3 months of screening.
Use of anticoagulants (oral, parenteral) or fibrinolytic therapy within 24 h prior to screening (Visit 1).
Known platelet disorders (e.g., thrombasthenia, thrombocytopenia, von Willebrand disease).
Storey RF, Gurbel PA, Ten Berg J, Bernaud C, Dangas GD, Frenoux JM, Gorog DA, Hmissi A, Kunadian V, James SK, Tanguay JF, Tran H, Trenk D, Ufer M, Van der Harst P, Van't Hof AWJ, Angiolillo DJ. Pharmacodynamics, pharmacokinetics, and safety of single-dose subcutaneous administration of selatogrel, a novel P2Y12 receptor antagonist, in patients with chronic coronary syndromes. Eur Heart J. 2020 Sep 1;41(33):3132-3140. doi: 10.1093/eurheartj/ehz807.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Of the 16 participants not randomized: 9 were ineligible; 4 withdrew consent; 1 was lost to follow-up, 1 was not randomized based on the physician's decision and 1 didn't complete screening within the protocol-defined window.
Recruitment Details
The study was conducted between 24 Jan and 18 Sep 2018. Twenty sites in 8 countries screened 362 participants and 17 sites randomized 346 participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Selatogrel 8 mg
The study had 3 consecutive periods: the screening period, a treatment period and the follow-up period.
A participant that met all inclusion criteria and none of the exclusion criteria was randomized.
In the treatment period 8 mg of selatogrel (ACT-246475) was administered via a single subcutaneous injection either in the abdomen or the thigh.
The follow-up period started on Day 3 and ended with the safety follow-up telephone call or visit (Day 35).
Periods
Title
Milestones
Reasons Not Completed
Randomized at End of Screening Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 31, 2017
Mar 22, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
Double-blinding will apply to treatment (ACT-246475 vs placebo). The dose (8 mg vs 16 mg) will be single blinded (subject blinded). The site for the sub-cutaneous injection (thigh vs abdomen) will not be blinded.
Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water for injection.
Selatogrel 16 mg
ACT-246575
Time to Reach Maximum Selatogrel Plasma Concentration (Tmax)
Time after subcutaneous injection to reach the maximum observed selatogrel plasma concentration (Cmax).
Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours
Area Under the Plasma Concentration-time Curve of Selatogrel From Time Zero to 24 Hour Time Point (AUC0-24)
The area under the plasma concentration-time curve is the integral of the concentration-time curve after subcutaneous injection of selatogrel.
The plasma pharmacokinetic parameters of selatogrel (ACT-246475) were derived by non-compartmental analyses of the plasma concentration-time profiles.
Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours post-dose
From 15 minutes after administration of the subcutaneous injection up to 24 hours
Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation - Sensitivity Analysis
To assess the robustness of results for the pharmacodynamic response, the main analysis was repeated for the per protocol participants. The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU of less than 100 starting from 30 minutes after the administration of study treatment and lasting for at least 3 hours was considered a "responder".
From 15 minutes after administration of the subcutaneous injection up to 24 hours
Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA)
Light transmission aggregometry was used as complementary method to the VerifyNow® to evaluate the effect of selatogrel on platelet aggregation. Platelet aggregation was triggered by addition of Adenosine diphosphate (ADP) 20 µM (micromole per liter) and monitored over 6 minutes. Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with 20 µM ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA % reflects stronger platelet inhibition, whereas a higher MPA % reflects weaker inhibition.
Pre-dose, and from 30 minutes after administration of the subcutaneous injection up to 8 hours
Number of Participants With Bleeding Events
Treatment-emergent adverse events in the category "Haemorrhage (excluding laboratory terms)" were of special interest and their incidence listed below.
The role of the Independent Safety Event Committee was to monitor unblinded safety data obtained in the study, with a specific focus on study-drug-related clinically relevant major bleeding events, occurring within 48 hours after dosing (i.e. the treatment period).
From study treatment administration on Day 1 up to 48 hours
Tampa
Florida
33613
United States
NorthShore University
Chicago
Illinois
73104
United States
Indiana University School of Medicine - Krannert Institute of Cardiology
Indianapolis
Indiana
46202
United States
Inova Cardiology
Lutherville
Maryland
21093
United States
Mount Sinai Hospital (New York)
New York
New York
10029
United States
Inova Center for Thrombosis Research and Translational Medicine
Falls Church
Virginia
22042
United States
Institut de Cardiologie de Montréal
Montreal
Quebec
H1T 1C8
Canada
Aarhus University Hospital
Aarhus
8200
Denmark
Rigshospitalet
Copenhagen
2100
Denmark
Universitats-Herzzentrum
Bad Krozingen
79189
Germany
University Medical Center Groningen
Groningen
9713 GZ
Netherlands
Maastricht UMC
Maastricht
6229 HX
Netherlands
St. Antonius Ziekenhuis
Nieuwegein
3435 CM
Netherlands
National Heart Centre Singapore
Singapore
169609
Singapore
Sahlgrenska University Hospital
Gothenburg
40530
Sweden
Uppsala University Hospital
Uppsala
18288
Sweden
Freeman Hospital - Cardiothoracic Department
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sheffield Teaching Hospitals
Sheffield
S5 7AU
United Kingdom
East & North Hertfordshire NHS Trust - Lister Hospital
Stevenage
SG14AB
United Kingdom
FG001
Selatogrel 16 mg
The study had 3 consecutive periods: the screening period, a treatment period and the follow-up period.
A participant that met all inclusion criteria and none of the exclusion criteria was randomized.
In the treatment period 16 mg of selatogrel (ACT-246475) was administered via a single subcutaneous injection either in the abdomen or the thigh.
The follow-up period started on Day 3 and ended with the safety follow-up telephone call or visit (Day 35).
FG002
Placebo
The study had 3 consecutive periods: the screening period, a treatment period and the follow-up period.
A participant that met all inclusion criteria and none of the exclusion criteria was randomized.
In the treatment period placebo matching selatogrel was administered via a single subcutaneous injection either in the abdomen or the thigh.
The follow-up period started on Day 3 and ended with the safety follow-up telephone call or visit (Day 35).
FG000115 subjects
FG001115 subjects
FG002116 subjects
COMPLETED
FG000114 subjects
FG001115 subjects
FG002116 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
Type
Comment
Reasons
Physician decision due to adverse event
FG0001 subjects
FG0010 subjects
FG0020 subjects
Treatment Period
Type
Comment
Milestone Data
STARTED
FG000114 subjects
FG001115 subjects
FG002116 subjects
Thigh Administration
FG00057 subjects
FG00157 subjects
FG00258 subjects
Abdomen Administration
FG00057 subjects
FG00158 subjects
FG00258 subjects
Per-protocol Analysis Set
The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
FG00096 subjects
FG00190 subjects
FG00293 subjects
Safety Analysis Set
The safety analysis set (SAF) includes all participants who received at least one dose of study treatment. Participants were evaluated according to the actual treatment they received.
FG000114 subjects
FG001115 subjects
FG002116 subjects
Pharmacokinetic Analysis Set
The PK analysis set includes all participants from the SAF who have at least one plasma concentration measurement after administration of study treatment. Participants in the PK set were evaluated according to the actual treatment they received.
FG000111 subjects
FG001115 subjects
FG0020 subjects
COMPLETED
FG000114 subjects
FG001115 subjects
FG002116 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
Follow-up Period
Type
Comment
Milestone Data
STARTED
FG000114 subjects
FG001115 subjects
FG002116 subjects
COMPLETED
FG000113 subjects
FG001115 subjects
FG002116 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
Full Analysis Set - all participants that were randomized and who had study treatment administered.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Selatogrel 8 mg
Selatogrel (ACT-246475) 8 mg was administered as a single subcutaneous dose.
BG001
Selatogrel 16 mg
Selatogrel (ACT-246475) 16 mg was administered as a single subcutaneous dose.
BG002
Placebo
Matching placebo was administered as a single subcutaneous dose.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000114
BG001115
BG002116
BG003345
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Per-protocol set - all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
Count of Participants
Participants
Title
Denominators
Categories
Full analysis set
ParticipantsBG000114
ParticipantsBG001115
ParticipantsBG002116
ParticipantsBG003
Age, Continuous
Per-protocol set - all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
Mean
Standard Deviation
years
Title
Denominators
Categories
Full analysis set
ParticipantsBG000114
ParticipantsBG001115
ParticipantsBG002
Sex: Female, Male
Per-protocol set - all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
Count of Participants
Participants
Title
Denominators
Categories
Full analysis set
ParticipantsBG000114
ParticipantsBG001115
ParticipantsBG002
Ethnicity (NIH/OMB)
Per-protocol set - all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
Count of Participants
Participants
Title
Denominators
Categories
Full analysis set
ParticipantsBG000114
ParticipantsBG001115
ParticipantsBG002
Race (NIH/OMB)
Per-protocol set - all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
Count of Participants
Participants
Title
Denominators
Categories
Full analysis set
ParticipantsBG000114
ParticipantsBG001115
ParticipantsBG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Canada
ParticipantsBG000114
ParticipantsBG001115
ParticipantsBG002
Body Mass Index
Per-protocol set - all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
Mean
Standard Deviation
kilograms per square meter (kg/m^2)
Title
Denominators
Categories
Full analysis set
ParticipantsBG000114
ParticipantsBG001115
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU of less than 100 starting from 30 minutes after the administration of study treatment and lasting for at least 3 hours was considered a "responder".
Full Analysis Set - all participants that were randomized and who had study treatment administered.
Posted
Number
Count of participants (i.e., responders)
From 15 minutes after administration of the subcutaneous injection up to 24 hours
ID
Title
Description
OG000
Selatogrel 8 mg
Selatogrel 8 mg was administered as a single subcutaneous dose.
OG001
Selatogrel 16 mg
Selatogrel 16 mg was administered as a single subcutaneous dose.
OG002
Placebo
Matching placebo was administered as a single subcutaneous dose.
Units
Counts
Participants
OG000114
OG001115
OG002116
Title
Denominators
Categories
Title
Measurements
OG000102
OG001103
OG00218
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
The study aimed at assessing the efficacy of each selatogrel dose versus placebo. The proportion of responders for each of the two doses of selatogrel was compared to placebo.
No imputation was considered for handling missing values.
Chi-squared
< 0.0001
A p-value significance level was set to 0.025, based on an overall Type-I error rate of 0.05 adjusted for multiple comparisons using a Bonferroni approach (two comparisons).
Odds Ratio (OR)
58.9
2-Sided
97.5
22.4
154.8
Superiority
Secondary
Maximum Selatogrel Plasma Concentration (Cmax)
The Cmax is the peak concentration of selatogrel in the plasma after subcutaneous injection.
The pharmacokinetic parameters of selatogrel (ACT-246475) were derived by non-compartmental analyses of the plasma concentration-time profiles.
Pharmacokinetic analysis set - all participants that had a selatogrel concentration measurement after administration of study treatment.
Posted
Geometric Mean
Full Range
ng/mL
Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours
ID
Title
Description
OG000
Selatogrel 8 mg
Selatogrel 8 mg was administered as a single subcutaneous dose.
OG001
Selatogrel 16 mg
Selatogrel 16 mg was administered as a single subcutaneous dose.
Units
Counts
Participants
OG000
Secondary
Time to Reach Maximum Selatogrel Plasma Concentration (Tmax)
Time after subcutaneous injection to reach the maximum observed selatogrel plasma concentration (Cmax).
Pharmacokinetic analysis set - all participants that had a selatogrel concentration measurement after administration of study treatment.
Posted
Median
Full Range
hour
Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours
ID
Title
Description
OG000
Selatogrel 8 mg
Selatogrel 8 mg was administered as a single subcutaneous dose.
OG001
Selatogrel 16 mg
Selatogrel 16 mg was administered as a single subcutaneous dose.
Units
Counts
Participants
OG000
Secondary
Area Under the Plasma Concentration-time Curve of Selatogrel From Time Zero to 24 Hour Time Point (AUC0-24)
The area under the plasma concentration-time curve is the integral of the concentration-time curve after subcutaneous injection of selatogrel.
The plasma pharmacokinetic parameters of selatogrel (ACT-246475) were derived by non-compartmental analyses of the plasma concentration-time profiles.
Pharmacokinetic analysis set - all participants that had a selatogrel concentration measurement after administration of study treatment.
Posted
Geometric Mean
Full Range
hours*ng/mL
Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours post-dose
ID
Title
Description
OG000
Selatogrel 8 mg
Selatogrel 8 mg was administered as a single subcutaneous dose.
OG001
Selatogrel 16 mg
Selatogrel 16 mg was administered as a single subcutaneous dose.
Units
Counts
Participants
Other Pre-specified
Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation by Site of Treatment Administration (Thigh or Abdomen)
The inhibition of platelet aggregation based on the route of administration, i.e. whether the pharmacodynamic response was different if selatogrel was administered subcutaneously in the thigh or in the abdomen, was analyzed.
The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU of less than 100 starting from 30 minutes after the administration of study treatment and lasting for at least 3 hours was considered a "responder".
Full Analysis Set - all participants that were randomized and who had study treatment administered.
Posted
Number
Count of participants (i.e., responders)
From 15 minutes after administration of the subcutaneous injection up to 24 hours
ID
Title
Description
OG000
Selatogrel 8 mg (Thigh)
Selatogrel 8 mg was administered as a single subcutaneous dose.
OG001
Selatogrel 8 mg (Abdomen)
Selatogrel 8 mg was administered as a single subcutaneous dose.
Other Pre-specified
Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation - Sensitivity Analysis
To assess the robustness of results for the pharmacodynamic response, the main analysis was repeated for the per protocol participants. The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU of less than 100 starting from 30 minutes after the administration of study treatment and lasting for at least 3 hours was considered a "responder".
Per-protocol set
Posted
Number
Count of participants (i.e., responders)
From 15 minutes after administration of the subcutaneous injection up to 24 hours
ID
Title
Description
OG000
Selatogrel 8 mg
Selatogrel 8 mg was administered as a single subcutaneous dose.
OG001
Selatogrel 16 mg
Selatogrel 16 mg was administered as a single subcutaneous dose.
OG002
Placebo
Matching placebo was administered as a single subcutaneous dose.
Other Pre-specified
Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA)
Light transmission aggregometry was used as complementary method to the VerifyNow® to evaluate the effect of selatogrel on platelet aggregation. Platelet aggregation was triggered by addition of Adenosine diphosphate (ADP) 20 µM (micromole per liter) and monitored over 6 minutes. Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with 20 µM ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA % reflects stronger platelet inhibition, whereas a higher MPA % reflects weaker inhibition.
Full Analysis Set - all participants that were randomized and who had study treatment administered.
Posted
Mean
Standard Deviation
percent maximum platelet aggregation (%)
Pre-dose, and from 30 minutes after administration of the subcutaneous injection up to 8 hours
ID
Title
Description
OG000
Selatogrel 8 mg
Selatogrel 8 mg was administered as a single subcutaneous dose.
OG001
Selatogrel 16 mg
Selatogrel 16 mg was administered as a single subcutaneous dose.
OG002
Other Pre-specified
Number of Participants With Bleeding Events
Treatment-emergent adverse events in the category "Haemorrhage (excluding laboratory terms)" were of special interest and their incidence listed below.
The role of the Independent Safety Event Committee was to monitor unblinded safety data obtained in the study, with a specific focus on study-drug-related clinically relevant major bleeding events, occurring within 48 hours after dosing (i.e. the treatment period).
The safety analysis set (SAF) included all participants who received at least one dose of study medication.
Posted
Count of Participants
Participants
From study treatment administration on Day 1 up to 48 hours
ID
Title
Description
OG000
Selatogrel 8 mg
Selatogrel 8 mg was administered as a single subcutaneous dose.
OG001
Selatogrel 16 mg
Selatogrel 16 mg was administered as a single subcutaneous dose.
OG002
Placebo
Matching placebo was administered as a single subcutaneous dose.
Post-Hoc
Assessments of the Inhibition of Platelet Reactivity at Predefined Time Points
The inhibition of platelet aggregation was determined using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). After single-dose administration the inhibition of platelet aggregation was measured at pre-defined timepoints to observe the platelet reactivity and aggregation over a 24-hour timeperiod. A lower PRU reflects lower platelet reactivity, whereas a higher PRU reflects higher platelet reactivity.
Full Analysis Set - all participants that were randomized and who had study treatment administered.
Posted
Mean
95% Confidence Interval
P2Y12 reaction units
Pre-dose (baseline) up to 24 hours post-dose injection
ID
Title
Description
OG000
Selatogrel 8 mg
Selatogrel 8 mg was administered as a single subcutaneous dose.
OG001
Selatogrel 16 mg
Selatogrel 16 mg was administered as a single subcutaneous dose.
OG002
Placebo
Matching placebo was administered as a single subcutaneous dose.
Time Frame
Adverse events were recorded up to 35 days after the single subcutaneous selatogrel dose administration. Treatment period: Treatment emergent adverse events were those adverse events with onset and up to 48 hours after study treatment administration. The follow-up period started on Day 3 and ended with the safety follow-up telephone call 35 days after selatogrel administration. During the follow-up period the participants continued to be observed. No interventions were performed.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Treatment Period - Selatogrel 8 mg
In the treatment period 8 mg of selatogrel was administered via a single subcutaneous injection either in the abdomen or the thigh.
0
114
0
114
36
114
EG001
Treatment Period - Selatogrel 16 mg
In the treatment period 16 mg of selatogrel was administered via a single subcutaneous injection either in the abdomen or the thigh.
0
115
0
115
26
115
EG002
Treatment Period - Placebo
In the treatment period placebo matching selatogrel was administered via a single subcutaneous injection either in the abdomen or the thigh.
0
116
0
116
25
116
EG003
Follow-up Period - Selatogrel 8 mg
Participants that had been administered a single subcutaneous injection containing 8 mg selatogrel in the treatment period were followed-up for adverse events after the treatment period. The follow-up period started on Day 3 and ended with a telephone call or visit on Day 35.
1
114
5
114
13
114
EG004
Follow-up Period - Selatogrel 16 mg
Participants that had been administered a single subcutaneous injection containing 16 mg selatogrel were followed-up for adverse events after the treatment period. The follow-up period started on Day 3 and ended with a telephone call or visit on Day 35.
0
115
1
115
10
115
EG005
Follow-up Period - Placebo
Participants that had been administered a single subcutaneous injection containing placebo matching selatogrel were followed-up for adverse events after the treatment period. The follow-up period started on Day 3 and ended with a telephone call or visit on Day 35.
0
116
1
116
13
116
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
Participant was hospitalized 26 days after study treatment administration.
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG0031 events1 affected114 at risk
Syncope
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
Participant was hospitalized 12 days after study treatment administration.
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (21.0)
Systematic Assessment
Participant was hospitalized 30 days after study treatment administration.
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
Participant was hospitalized 12 days after study treatment administration.
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
Participant was hospitalized 14 days after study treatment administration.
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Myocardial infarctions
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
Participant was hospitalized 18 days after study treatment administration.
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
Participant died 18 days after study treatment administration.
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
Participant died 18 days after study treatment administration.
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hypertension
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected115 at risk
EG0022 events2 affected116 at risk
EG0030 events0 affected114 at risk
EG0040 events0 affected115 at risk
EG0050 events0 affected116 at risk
Hypotension
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Injection site bruise
General disorders
MedDRA (21.0)
Systematic Assessment
EG0003 events3 affected114 at risk
EG0012 events2 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Injection site erythema
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0012 events2 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Injection site pruritus
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0012 events2 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Injection site reaction
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Medical device site bruising
General disorders
MedDRA (21.0)
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Oedema peripheral
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Peripheral swelling
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected116 at risk
EG003
Pyrexia
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Vessel puncture site bruise
General disorders
MedDRA (21.0)
Systematic Assessment
EG0006 events4 affected114 at risk
EG0010 events0 affected115 at risk
EG0024 events3 affected116 at risk
EG003
Vessel puncture site erythema
General disorders
MedDRA (21.0)
Systematic Assessment
EG0002 events2 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Vessel puncture site haematoma
General disorders
MedDRA (21.0)
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected116 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0001 events1 affected114 at risk
EG0011 events1 affected115 at risk
EG0023 events3 affected116 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Procedural dizziness
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Procedural nausea
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Wound haemorrhage
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected116 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected116 at risk
EG003
Blood potassium increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
White blood cell count increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected116 at risk
EG003
ECG P wave inverted
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0005 events5 affected114 at risk
EG0014 events4 affected115 at risk
EG0021 events1 affected116 at risk
EG003
Headache
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0003 events3 affected114 at risk
EG0013 events3 affected115 at risk
EG0025 events5 affected116 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected116 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected116 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0002 events2 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0004 events4 affected114 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected116 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected115 at risk
EG0021 events1 affected116 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected116 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected116 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected116 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected116 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected116 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0001 events1 affected114 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Chemical burns of eye
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Renal pain
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Malaise
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Pain in extremity
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Blood glucose increased
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Fatigue
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Iron deficiency
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0006 events6 affected114 at risk
EG00110 events10 affected115 at risk
EG0020 events0 affected116 at risk
EG003
Blood was collected with phenylalanine-proline-arginine-chloromethyl ketone as anticoagulant. Any direct comparison of absolute PRU values obtained in this study with those published from studies of other P2Y12 inhibitors should take this into account.
The study aimed at assessing the efficacy of each selatogrel dose versus placebo. The proportion of responders for each of the two doses of selatogrel was compared to placebo.
No imputation was considered for handling missing values in the main analysis.
Chi-squared
< 0.0001
A p-value significance level was set to 0.025, based on an overall Type-I error rate of 0.05 adjusted for multiple comparisons using a Bonferroni approach (two comparisons).
Odds Ratio (OR)
61.2
2-Sided
97.5
23.1
162.3
Superiority
111
OG001115
Title
Denominators
Categories
Title
Measurements
OG000298(146 to 868)
OG001484(161 to 1030)
111
OG001115
Title
Denominators
Categories
Title
Measurements
OG0000.52(0.38 to 1.05)
OG0010.53(0.23 to 2.02)
OG000
111
OG001115
Title
Denominators
Categories
Title
Measurements
OG000716(347 to 1425)
OG0011358(487 to 2758)
OG002
Selatogrel 16 mg (Thigh)
Selatogrel 16 mg was administered as a single subcutaneous dose.
OG003
Selatogrel 16 mg (Abdomen)
Selatogrel 16 mg was administered as a single subcutaneous dose.
OG004
Placebo (Thigh)
Matching placebo was administered as a single subcutaneous dose.
OG005
Placebo (Abdomen)
Matching placebo was administered as a single subcutaneous dose.
Units
Counts
Participants
OG00057
OG00157
OG00257
OG00358
OG00458
OG00558
Title
Denominators
Categories
Title
Measurements
OG00052
OG00150
OG00252
OG00351
OG00411
OG0057
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Chi-squared
0.1915
Other
Logistic regression (Type III analysis)
Units
Counts
Participants
OG00096
OG00190
OG00293
Title
Denominators
Categories
Title
Measurements
OG00092
OG00190
OG00216
Placebo
Matching placebo was administered as a single subcutaneous dose.
Units
Counts
Participants
OG000114
OG001115
OG002116
Title
Denominators
Categories
Pre-dose
ParticipantsOG000113
ParticipantsOG001112
ParticipantsOG002115
Title
Measurements
OG00061.9± 29.79
OG00162.4± 31.5
OG00265.6± 29.6
30 minutes post-dose
ParticipantsOG000114
ParticipantsOG001109
ParticipantsOG002109
Title
Measurements
OG000
1 hour post-dose
ParticipantsOG000113
ParticipantsOG001109
ParticipantsOG002114
Title
Measurements
OG000
2 hours post-dose
ParticipantsOG000113
ParticipantsOG001113
ParticipantsOG002114
Title
Measurements
OG000
8 hours post-dose
ParticipantsOG000114
ParticipantsOG001113
ParticipantsOG002112
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Longitudinal analysis of the treatment effect, from start of treatment to 8 hours after injection.
Mixed Models Analysis
P-value significance level is set to 0.025, i.e. type I error (0.05) adjusted for multiplicity (2 comparisons) using a Bonferroni approach.
<.0001
LS Mean difference with placebo
-27.49
2-Sided
95
-35.4
-19.6
Other
OG001
OG002
Longitudinal analysis of the treatment effect, from start of treatment up to 8 hours after injection.
Mixed Models Analysis
P-value significance level is set to 0.025, i.e. type I error (0.05) adjusted for multiplicity (2 comparisons) using a Bonferroni approach
<.0001
LS Mean difference with placebo
-31.06
2-Sided
95
-39.0
-23.1
Other
Units
Counts
Participants
OG000114
OG001115
OG002116
Title
Denominators
Categories
All participants with at least one "bleeding event"
Title
Measurements
OG00011
OG0015
OG0028
Participants with Trombolysis In Myocardial Infarction (TIMI) major events
Title
Measurements
OG0000
OG0010
OG0020
Participants with "Bleeding event of moderate intensity"
Title
Measurements
OG0000
OG0010
OG0021
Participants with "Bleeding event of mild intensity"