Study of Platelet Function After Administration of Aspirin Versus Lysine Acetylsalicylate in STEMI Patients (ECCLIPSE-STEMI)

October 10, 2016 updated by: David Vivas, Fundacion Investigacion Interhospitalaria Cardiovascular

Effects of Intravenous Lysine Acetylsalicylate Versus Oral Aspirin on Platelet Responsiveness in Patients With ST-segment Elevation Myocardial Infarction: a Pharmacodynamic Study (ECCLIPSE-STEMI Trial)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Fundacion
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Investigacion Interhospitalaria Cardiovascular

Investigators

  • Principal Investigator: David Vivas, MD, PhD, San Carlos University Hospital, Madrid, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

October 8, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 11, 2016

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-ECCLIPSESTEMI-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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