Persistent Platelet Reactivity in Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

Official title:

Persistent Platelet Reactivity in Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02038309
• Other study ID #: PPRACS
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2014
• Last updated: January 15, 2014
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2014
• Source: Hopital Lariboisière
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• acute coronary syndrome with elevation in troponin

Exclusion Criteria:

• anticoagulant treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
France	Department of Cardiology - Lariboisiere Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Lariboisière

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major cardiovascular and cerebrovascular events (MACCE)	Major cardiovascular and cerebrovascular events : death, myocardial infarction, stroke, rehospitalisation and bleeding (academic research consortium) events at 1 year	one year	No
Other	microvascular resistance index	measurement during primary PCI on admission	Day 1	No
Primary	maximum aggregation intensity	Light transmission aggregometry following exposition to arachidonic acid 0.5mg/ml during the acute phase (day2-day 5)	day 2	No
Secondary	Maximum aggregation intensity	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	No
Secondary	Maximum aggregation intensity	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)	No