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

Primary Purpose

Ischemic Stroke

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Aspirin
blood sample
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring aspirin, platelet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital centralRecruiting

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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
For patients already treated with a daily dose of aspirin, a supplementary withdrawn was done before aspirin intake.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.

Full Information

First Posted
June 16, 2011
Last Updated
June 20, 2011
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT01375400
Brief Title
Effect of Aspirin at the Acute Phase of Cerebral Ischemic Event.
Acronym
Aspirin
Official Title
Laboratory Effect on Platelet Activity of the First 300 mg Oral Dose Aspirin at the Acute Phase of Cerebral Ischemic Event.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
aspirin, platelet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Administration of 300 mg of aspirin, per os.
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Description
2 blood samples will be performed
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sébastien Richard, MD
Phone
3 83 85 16 56
Ext
0 33
Email
s.richard@chu-nancy.fr
Facility Information:
Facility Name
Hopital central
City
Nancy
ZIP/Postal Code
54035
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien Richard, MD
Phone
3 83 85 16 56
Ext
33 0
Email
s.richard@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Sébastien Richard, MD

12. IPD Sharing Statement

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

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