Persistent Platelet Reactivity in Acute Coronary Syndrome

January 15, 2014 updated by: Dr Jean-Guillaume DILLINGER, Hopital Lariboisière
Study of persistent platelet reactivity during acute coronary syndrome. Patients are included at admission to the hospital. Platelet aggregation is evaluated by platelet function testing after blood sampling during hospitalization. No changes in treatment is planned.

Study Overview

Status

Unknown

Conditions

Detailed Description

Blood samples are performed on day 2 and 4 and collected with usual blood samples and analyzed by the laboratory. Maximal aggregation intensity and velocity are measured by light transmission aggregometry induced by arachidonic acid (AA) or adenosine diphosphate (ADP). Platelet function analyzer will be also used. No changes in treatment in response to the results is planned.

Study Type

Observational

Enrollment (Anticipated)

500

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

  • France
      • Paris, France, 75010
        • Recruiting
        • Department of Cardiology - Lariboisiere Hospital
        • Contact:
        • Principal Investigator:
          • Jean-Guillaume Dillinger, MD

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

Sampling Method

Probability Sample

Study Population

Acute coronary syndrome

Description

Inclusion Criteria:

  • acute coronary syndrome with elevation in troponin

Exclusion Criteria:

  • anticoagulant treatment

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum aggregation intensity
Time Frame: day 2
Light transmission aggregometry following exposition to arachidonic acid 0.5mg/ml during the acute phase (day2-day 5)
day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum aggregation intensity
Time Frame: Day 2
Light transmission aggregometry following exposition to adenosine diphosphate during the acute phase (day2-day 5) and during the chronic phase (day 30-day 60)
Day 2
Maximum aggregation intensity
Time Frame: Chronic phase (day 30 to day 60)
Light transmission aggregometry following exposition to arachidonic acid 0.5mg/ml during the chronic phase (day 30-day 60)
Chronic phase (day 30 to day 60)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major cardiovascular and cerebrovascular events (MACCE)
Time Frame: one year
Major cardiovascular and cerebrovascular events : death, myocardial infarction, stroke, rehospitalisation and bleeding (academic research consortium) events at 1 year
one year
microvascular resistance index
Time Frame: Day 1
measurement during primary PCI on admission
Day 1

Collaborators and Investigators

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

Sponsor

Hopital Lariboisière

Investigators

  • Study Director: Patrick Henry, MD-PhD, Department of Cardiology - Lariboisiere Hospital - APHP

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

January 1, 2013

Primary Completion (Anticipated)

November 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 12, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimate)

January 16, 2014

Study Record Updates

Last Update Posted (Estimate)

January 17, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPRACS

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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