Persistent Platelet Reactivity in Acute Coronary Syndrome | NCT02038309

Studies
Persistent Platelet Reactivity in Acute Coronary Syndrome

NCT02038309

Sponsor

Hopital Lariboisière

Status

Completed

Last Update Posted

Jul 25, 2024Actual

Enrollment

106Actual

Phase

Not provided

Conditions

Acute Coronary Syndrome

Interventions

Not provided

Countries

France

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

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jan 12, 2014

First Submission Date that Met QC Criteria

Jan 14, 2014

First Posted Date

Jan 16, 2014Estimated

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

Jul 24, 2024

Last Update Posted Date

Jul 25, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Jean-Guillaume DILLINGER, Department of Cardiology, Hopital LariboisièrePrincipal Investigator

Lead Sponsor

Hopital LariboisièreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

106Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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
Maximum aggregation intensity

Other Outcomes

Measure	Description	Time Frame
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
microvascular resistance index

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acute coronary syndrome with elevation in troponin

Exclusion Criteria:

anticoagulant treatment

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

Acute coronary syndrome

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick Henry, MD-PhD	Department of Cardiology - Lariboisiere Hospital - APHP	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology - Lariboisiere Hospital		Paris		75010	France

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided