Effect of Aspirin at the Acute Phase of Cerebral Ischemic Event. (Aspirin)

June 20, 2011 updated by: Central Hospital, Nancy, France

Laboratory Effect on Platelet Activity of the First 300 mg Oral Dose Aspirin at the Acute Phase of Cerebral Ischemic Event.

Aspirin is the only anti-platelet medication used at the acute phase of ischemic stroke. The investigators would like to study laboratory effect of the first oral 300 mg dose of aspirin, given at hospital, after an ischemic event.

The principal hypothesis is that platelet activity would be able to recover during this day and could lead to ischemic recurrences.

Two blood samples are accomplished. The first 2 hours after aspirin intake and the second 23 hours after. Photometric aggregometry are performed with arachidonic acid and collagen induced platelet aggregation, measure of thromboxan B2 levels and reticular platelets count.

Study Overview

Status

Unknown

Conditions

Ischemic Stroke

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

Phase

Not Applicable

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
- - Nancy, France, 54035
    - Recruiting
    - Hôpital Central
    - Principal Investigator:
      
      Sébastien Richard, MD
    - Contact:
      
      Sébastien Richard, MD
      
      Phone Number: 33 0 3 83 85 16 56
      
      Email: s.richard@chu-nancy.fr

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

Adult men and women
Ischemic stroke less than 48 hours
Signed consent

Exclusion Criteria:

Danger to prescription of aspirin (haemorrhagic risk...)
Prescription of heparin or VKA

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: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of platelet activity recovery within 24 hours after the first 300 mg oral dose of aspirin given at hospital at the acute phase of ischemic stroke Time Frame: 1 month	We study laboratory parameters of the first 300 mg oral dose of aspirin given, within 48 hours, after ischemic cerebral event. For all patients, two blood sampling are performed, the first, during the third hour after aspirin intake and the second during the twenty-fourth hour. Platelet reactivity is studied on the basis of serum thromboxane B2 levels and light transmission aggregometry after stimulation of platelet-rich plasma by acid arachidonic and collagen 2µg/ml reported to results with collagen 20 µg/ml.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of effect of the first 300 mg oral dose of aspirin given at the acute phase of cerebral ischemic stroke for already aspirin treated Time Frame: 1 month	For patients already treated with a daily dose of aspirin, a supplementary withdrawn was done before aspirin intake. Platelet reactivity was studied on the basis of serum thromboxane B2 levels and light transmission aggregometry after stimulation of platelet-rich plasma by acid arachidonic and collagen 2µg/ml reported to results with collagen 20 µg/ml.	1 month

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

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

December 1, 2010

Primary Completion (Anticipated)

July 1, 2011

Study Registration Dates

First Submitted

June 16, 2011

First Submitted That Met QC Criteria