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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000765-36 | EudraCT Number |
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The goal of this study is to find out how fast a drug called selatogrel (ACT-246475) can prevent platelets from binding together. This study will also help to find out more about the safety of this new drug. The drug selatogrel (ACT-246475) will be used in 2 different doses (8 mg or 16 mg) and will be administered in the thigh.
This study is planned in patients presenting with Acute Myocardial Infarction (AMI) scheduled for an invasive strategy. Platelet activation and thrombus formation play a pivotal role in the pathophysiology of acute coronary syndrome. Early platelet inhibition has been shown to reduce the risk of recurrent events after a myocardial infarction.
The screening period starts when the participant provides informed consent and ends with participant's randomization. Eligible participants had an acute myocardial infarction (AMI; ST-segment elevation myocardial infarction [STEMI] or non-ST-elevation myocardial infarction [NSTEMI]), a life-threatening condition, and will therefore fulfill the ICH-GCP definition of vulnerable subjects ("persons in emergency situations"). Accordingly, a specific process for obtaining consent in compliance with local regulations and approved by the independent ethics committee will be implemented.
The study will be performed during a participant's hospital stay related to the qualifying AMI.
Standard treatment of AMI is allowed including anticoagulants. Ticagrelor will be the only oral P2Y12 receptor antagonist allowed to be initiated during the study and its administration will be possible only after selatogrel administration. Use of fibrinolytics or GPIIb/IIIa inhibitors will be prohibited unless required for bail-out. All other standard-of-care treatments for AMI will be allowed without restriction.
The treatment period starts with the participant's randomization and ends after the end-of-study assessments, approximately 48 hours after the administration of a single study treatment dose.
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| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selatogrel 8 mg | 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) will be reconstituted with 1 mL of water and further diluted with 1 mL sodium chloride (NaCl) 0.9%. |
| 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 the VerifyNow® assay. 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 less than 100 at 30 minutes post-dose was counted as a participant that had a pharmacodynamic response. | 30 minutes after the administration of the subcutaneous injection |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants (Per-protocol Subgroup) 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 at 30 minutes post-dose was counted as a participant that had a pharmacodynamic response. |
Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Viatris Innovation GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Ziekenhuis Aalst | Aalst | 9300 | Belgium | |||
| UZLeuven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20194878 | Background | Gurbel PA, Bliden KP, Butler K, Antonino MJ, Wei C, Teng R, Rasmussen L, Storey RF, Nielsen T, Eikelboom JW, Sabe-Affaki G, Husted S, Kereiakes DJ, Henderson D, Patel DV, Tantry US. Response to ticagrelor in clopidogrel nonresponders and responders and effect of switching therapies: the RESPOND study. Circulation. 2010 Mar 16;121(10):1188-99. doi: 10.1161/CIRCULATIONAHA.109.919456. Epub 2010 Mar 1. | |
| 16621870 |
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Forty-eight patients were randomized to either selatogrel 8 mg or 16 mg. Forty-seven patients were administered selatogrel and completed the study. One patient randomized to the 8 mg group did not receive selatogrel (not treated for administrative reasons) and was excluded from the full-analysis set (FAS).
The study was conducted between 10 July and 10 November 2018. Seven sites were initiated. Six sites in 3 countries screened and randomized 48 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Selatogrel 8 mg | A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh. |
| FG001 | Selatogrel 16 mg | A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization |
|
| ||||||||||||||||||
| Treatment Period |
|
Full Analysis Set (all participants that were treated).
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| ID | Title | Description |
|---|---|---|
| BG000 | Selatogrel 8 mg | A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh. |
| BG001 | Selatogrel 16 mg | A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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). |
| 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 the VerifyNow® assay. 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 less than 100 at 30 minutes post-dose was counted as a participant that had a pharmacodynamic response. | The modified full analysis set (mFAS) includes all participants from the FAS who have an assessment of the primary endpoint (that is all participants with a 30-min post dose VerifyNow® blood sample analysis). | Posted | Number | Count of participants | 30 minutes after the administration of the subcutaneous injection |
|
Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Selatogrel 8 mg | A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular tachycardia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic stenosis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
The p-values need to be cautiously interpreted due to the small study population size.
The participants were expected per protocol to shortly undergo invasive management, it was anticipated that most would receive an early loading dose of ticagrelor.
Blood samples were collected with phenylalanine-proline-arginine-chloromethylketone as anticoagulant.
Only the VerifyNow® assay was used to assess the platelet response to selatogrel.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Viatris Innovation Clinical Trial Information | Viatris Innovation GmbH | +41 58 844 07 44 | viatrisinnovationclinicaltrials@viatris.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 11, 2018 | Jul 27, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2018 | Jul 27, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000601315 | selatogrel |
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|
|
| Selatogrel 16 mg | 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) will be reconstituted with 1 mL of water for injection. |
|
|
| 30 minutes after the administration of the subcutaneous injection |
| Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation | The purpose of this supportive analysis was to assess the effect when relaxing the time of a PRU < 100, i.e., considering as a response a PRU < 100 at 15, 30 or 60 min. post injection. The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using the VerifyNow® assay. 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 less than 100 post-dose was counted as a participant that had a pharmacodynamic response. | pre-dose, 15, 30 and 60 minutes after the administration of the subcutaneous injection |
| Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time | The pharmacodynamic response assessed by the inhibition of adenosine diphosphate (ADP)-mediated platelet aggregation was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test. The results are expressed as P2Y12 reaction units (PRU). | pre-dose, 15, 30 and 60 minutes after administration of the subcutaneous injection |
| 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, 15, 30 and 60 minutes and 8 hours after the administration of the subcutaneous injection |
| Time to Reach Maximum Selatogrel Plasma Concentration (Tmax) | Time after subcutaneous injection to reach the maximum observed selatogrel plasma concentration (Cmax). | pre-dose, 15, 30 and 60 minutes and 8 hours after the administration of the subcutaneous injection |
| Leuven |
| 3000 |
| Belgium |
| Galilee Medical Center | Nahariya | 22100 | Israel |
| Universitätsspital Basel | Basel | 4031 | Switzerland |
| University Hospital Bern | Bern | 3010 | Switzerland |
| Cardiocentro Ticino | Lugano | 6900 | Switzerland |
| Background |
| Jernberg T, Payne CD, Winters KJ, Darstein C, Brandt JT, Jakubowski JA, Naganuma H, Siegbahn A, Wallentin L. Prasugrel achieves greater inhibition of platelet aggregation and a lower rate of non-responders compared with clopidogrel in aspirin-treated patients with stable coronary artery disease. Eur Heart J. 2006 May;27(10):1166-73. doi: 10.1093/eurheartj/ehi877. Epub 2006 Apr 18. |
| 24890542 | Background | Parodi G, Bellandi B, Valenti R, Migliorini A, Marcucci R, Carrabba N, Giurlani L, Gensini GF, Abbate R, Antoniucci D. Comparison of double (360 mg) ticagrelor loading dose with standard (60 mg) prasugrel loading dose in ST-elevation myocardial infarction patients: the Rapid Activity of Platelet Inhibitor Drugs (RAPID) primary PCI 2 study. Am Heart J. 2014 Jun;167(6):909-14. doi: 10.1016/j.ahj.2014.03.011. Epub 2014 Apr 4. |
| 32439008 | Derived | Sinnaeve P, Fahrni G, Schelfaut D, Spirito A, Mueller C, Frenoux JM, Hmissi A, Bernaud C, Ufer M, Moccetti T, Atar S, Valgimigli M. Subcutaneous Selatogrel Inhibits Platelet Aggregation in Patients With Acute Myocardial Infarction. J Am Coll Cardiol. 2020 May 26;75(20):2588-2597. doi: 10.1016/j.jacc.2020.03.059. |
| Per Protocol Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
| No |
|
| Age, Continuous | 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). | Mean | Standard Deviation | years |
|
| Sex: Female, Male | 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). | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | 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). | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | 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). | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | at screening visit | Mean | Standard Deviation | kilograms per square meter |
|
| Medical history risk factors at baseline | Count of Participants | Participants | No |
|
| Diagnosis at enrollment | Eligible participants presented with acute myocardial infarction (STEMI [ST-segment elevation myocardial infarction] or NSTEMI [Non-ST-segment elevation myocardial infarction]). | Count of Participants | Participants | No |
|
| STEMI: Thrombolysis in myocardial infarction (TIMI) risk score | The TIMI score is used to make clinical decisions about patient management and predicting the likelihood of adverse cardiac events. In STEMI participants the score ranges from 0 to 14. A higher TIMI score indicates a higher risk of adverse cardiac events. TIMI scores below 3 constitute a low risk of cardiac adverse events in the next month. TIMI scores of 3 and above constitute a moderate to high risk. | Participants diagnosis at enrollment with STEMI (ST-segment elevation myocardial infarction) | Count of Participants | Participants | No |
|
| NSTEMI: Thrombolysis in myocardial infarction (TIMI) risk score | The TIMI score is used to make clinical decisions about patient management and predicting the likelihood of adverse cardiac events. In NSTEMI participants scores range from 0 to 7. A higher TIMI score indicates a higher risk of adverse cardiac events. Scores of less than 5 constitutes a low risk of adverse cardiac events in the next 14 days and scores of 5 and above constitute a moderate to high risk. | Participants diagnosis at enrollment with NSTEMI (Non-ST-segment elevation myocardial infarction) | Count of Participants | Participants | No |
|
| Time from onset of acute myocardial infarction symptoms to treatment start | Mean | Standard Deviation | hours |
|
A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
| OG001 | Selatogrel 16 mg | A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh. |
|
|
|
| Other Pre-specified | Number of Participants (Per-protocol Subgroup) 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 at 30 minutes post-dose was counted as a participant that had a pharmacodynamic response. | Supportive analysis of the primary endpoint: per-protocol set | Posted | Number | Count of participants | 30 minutes after the administration of the subcutaneous injection |
|
|
|
|
| Other Pre-specified | Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation | The purpose of this supportive analysis was to assess the effect when relaxing the time of a PRU < 100, i.e., considering as a response a PRU < 100 at 15, 30 or 60 min. post injection. The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using the VerifyNow® assay. 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 less than 100 post-dose was counted as a participant that had a pharmacodynamic response. | Full analysis set | Posted | Number | Count of participants | pre-dose, 15, 30 and 60 minutes after the administration of the subcutaneous injection |
|
|
|
| Other Pre-specified | Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time | The pharmacodynamic response assessed by the inhibition of adenosine diphosphate (ADP)-mediated platelet aggregation was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test. The results are expressed as P2Y12 reaction units (PRU). | Full Analysis Set | Posted | Median | Inter-Quartile Range | P2Y12 reaction units (PRU) | pre-dose, 15, 30 and 60 minutes after administration of the subcutaneous injection |
|
|
|
| Other Pre-specified | 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 at least one selatogrel concentration measurement after administration of study treatment. | Posted | Geometric Mean | Full Range | ng/mL | pre-dose, 15, 30 and 60 minutes and 8 hours after the administration of the subcutaneous injection |
|
|
|
| Other Pre-specified | 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 at least one selatogrel concentration measurement after administration of study treatment. | Posted | Median | Full Range | hours | pre-dose, 15, 30 and 60 minutes and 8 hours after the administration of the subcutaneous injection |
|
|
|
| Post-Hoc | Subgroup Analyses: 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 at 30 minutes post-dose was counted as a participant that had a pharmacodynamic response. | Full Analysis Set | Posted | Number | Count of participants | 30 minutes after the administration of the subcutaneous injection |
|
|
|
| 0 |
| 24 |
| 1 |
| 24 |
| 12 |
| 24 |
| EG001 | Selatogrel 16 mg | A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh. | 0 | 23 | 1 | 23 | 7 | 23 |
| Arteriovenous fistula | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Vascular pseudoaneurysm | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Mitral valve stenosis | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nodal rhythm | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
As per the main analysis (mFAS) the supporting analysis on the per-protocol set this analysis of treatment effect was conducted independently for each dose, i.e., 8 and 16 mg.
| One-sided Z-test |
| 0.0201 |
P-value for hypotheses (H0: p <= 85% versus H1: p > 85%) |
| Superiority |
| 30 minutes post-dose |
|
| 60 minutes post-dose |
|
| 30 minutes post-dose |
|
| 60 minutes post-dose |
|
| Age 55 years and older |
|
|
| Male |
|
|
| Female |
|
|
| Body Mass Index less than 25 |
|
|
| Body Mass Index less than 25 and up to 30 |
|
|
| Body Mass Index greater than 30 |
|
|
| Diabetes mellitus at baseline |
|
|
| No diabetes mellitus at baseline |
|
|
| Chronic kidney disease at baseline |
|
|
| No Chronic kidney disease at baseline |
|
|
| STEMI at baseline |
|
|
| NSTEMI at baseline |
|
|