Study of Platelet Function After Administration of Aspiri... | NCT02929888

Studies
Study of Platelet Function After Administration of Aspirin Versus Lysine Acetylsalicylate in STEMI Patients

NCT02929888

Sponsor

Fundacion Investigacion Interhospitalaria Cardiovascular

Status

Unknown status

Last Update Posted

Oct 11, 2016Estimated

Enrollment

60Estimated

Phase

Phase 2Phase 3

Conditions

Acute Myocardial Infarction

Interventions

Lysine Acetilsalicilate
Aspirin

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Jul 2017Estimated

Completion Date

Not provided

First Submitted Date

Oct 8, 2016

First Submission Date that Met QC Criteria

Oct 10, 2016

First Posted Date

Oct 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2016

Last Update Posted Date

Oct 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Vivas, MD, PhD, Fundacion Investigacion Interhospitalaria CardiovascularPrincipal Investigator

Lead Sponsor

Fundacion Investigacion Interhospitalaria CardiovascularOTHER

Collaborators

Not provided

Description Module

Brief Summary

Prasugrel and ticagrelor, new P2Y12-ADP receptor antagonists, are associated with greater pharmacodynamic inhibition and reduction of cardiovascular events in patients with an acute coronary syndrome. However, evidence is lacked about the effects of achieving faster and stronger cyclooxygenase inhibition with intravenous lysine acetylsalicylate (LA) compared to oral aspirin on prasugrel inhibited platelets. Recently, we demonstrated in healthy volunteers that the administration of intravenous LA resulted in a significantly reduction of platelet reactivity compared to oral aspirin on prasugrel inhibited platelets. Loading dose of LA achieves platelet inhibition faster, greater and with less variability than aspirin. However, there are no data of this issue in patients with an ST-segment elevation myocardial infarction (STEMI). The ECCLIPSE-STEMI trial will study the effect of LA versus aspirin in platelet reactivity in patients with STEMI

Detailed Description

This is a prospective, randomized, single-center, open platelet function study conducted in 60 STEMI patients. Subjects were randomly assigned to receive a loading dose (LD) of intravenous LA 450mg plus oral prasugrel 60mg/ticagrelor 180mg, or LD of aspirin 300mg plus prasugrel 60mg/ticagrelor 180mg orally. Platelet function was evaluated at baseline, 30 min, 1h, 4h, and 24h using multiple electrode aggregometry and vasodilator-stimulated phosphoprotein phosphorylation (VASP). The primary endpoint of the study is the inhibition of platelet aggregation after arachidonic acid (AA) 1.5mM at 30 min. Secondary endopoints are the inhibition of platelet aggregation after AA baseline and at 1h, 4h and 24h, and measurement of aggregation with other platelet test (ADP, collagen and VASP).

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lysine Acetilsalicilate (LA)	Experimental	Loading dose (LD) of intravenous LA 450mg plus oral prasugrel 60mg/ticagrelor 180mg in patients with ST-segment elevation myocardial infarction	Drug: Lysine Acetilsalicilate
Aspirin	Active Comparator	Loading dose (LD) of oral aspirin 300mg plus oral prasugrel 60mg/ticagrelor 180mg in patients with ST-segment elevation myocardial infarction	Drug: Aspirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lysine Acetilsalicilate	Drug		Lysine Acetilsalicilate (LA)
Aspirin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Inhibition of platelet aggregation	The primary endpoint of the study, inhibition of platelet aggregation after arachidonic acid (AA) 1.5mM at 30 min	30 min

Secondary Outcomes

Measure	Description	Time Frame
Inhibition of platelet aggregation	Inhibition of platelet aggregation using different platelet function test (ADP, collagen, VASP)	30 min, 1h, 4h, 24h

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged > 18.
Patients with ST-segment myocardial infarction.
Signed written informed consent.

Exclusion Criteria:

Known allergies to aspirin, clopidogrel, prasugrel or ticagrelor.
Cardiogenic shock or hemodinamic instability.
Recent antiplatelet therapy (<14 days).
Oral anticoagulation with a coumarin derivative.
Any active bleeding or blood dyscrasia.
Recent gastrointestinal bleeding (<6 months prior to inclusion).
Recent history of stroke, TIA or intracranial bleeding (<6 months prior to inclusion).
Known anemia, trombopenia or severe chronic kidney/liver disease
Any known active neoplasm.
Pregnant females.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David Vivas, MD, PhD	Contact	0034 913303149	3149	dvivas@secardiologia.es

Overall Officials

Name	Affiliation	Role
David Vivas, MD, PhD	San Carlos University Hospital, Madrid, Spain	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fundacion	Recruiting	Madrid	Madrid	28040	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36480147	Derived	Vivas D, Jimenez JJ, Martin-Asenjo R, Bernardo E, Ortega-Pozzi MA, Gomez-Polo JC, Moreno G, Vilacosta I, Perez-Villacastin J, Fernandez-Ortiz A. Effects of intravenous lysine acetylsalicylate versus oral aspirin on platelet responsiveness in patients with ST-segment elevation myocardial infarction: the ECCLIPSE-STEMI trial. J Thromb Thrombolysis. 2023 Feb;55(2):203-210. doi: 10.1007/s11239-022-02737-y. Epub 2022 Dec 8.

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives