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

Ischemic Stroke Clinical Trial

— Aspirin  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01375400
• Other study ID #: Aspirin
• Status: Unknown status
• Phase: N/A
• First received: June 16, 2011
• Last updated: June 20, 2011
• Start date: December 2010

Study information

• Verified date: June 2011
• Source: Central Hospital, Nancy, France
• Contact: Sébastien Richard, MD
• Phone: 3 83 85 16 56
• Email: s.richard[@]chu-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke

Intervention

Drug:
• Aspirin
Administration of 300 mg of aspirin, per os.

Biological:
• blood sample
2 blood samples will be performed

Locations

Country	Name	City	State
France	Hopital central	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Secondary	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.	1 month