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

This study is currently recruiting participants.
Verified June 2011 by Central Hospital, Nancy, France
Sponsor:
Information provided by:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01375400
First received: June 16, 2011
Last updated: June 20, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Ischemic Stroke
 Drug: Aspirin
Biological: blood sample

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laboratory Effect on Platelet Activity of the First 300 mg Oral Dose Aspirin at the Acute Phase of Cerebral Ischemic Event.

Resource links provided by NLM:

Drug Information available for: Aspirin
U.S. FDA Resources

Further study details as provided by Central Hospital, Nancy, France:

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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: December 2010
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Aspirin
    Administration of 300 mg of aspirin, per os.
    Biological: blood sample
    2 blood samples will be performed
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375400

Contacts
Contact: Sébastien Richard, MD 3 83 85 16 56 ext 0 33 s.richard@chu-nancy.fr

Locations
France
Hopital central Recruiting
Nancy, France, 54035
Contact: Sébastien Richard, MD     3 83 85 16 56 ext 33 0     s.richard@chu-nancy.fr    
Principal Investigator: Sébastien Richard, MD            
Sponsors and Collaborators
Central Hospital, Nancy, France
  More Information

No publications provided

Responsible Party: Direction recherche et innovation CHU Nancy, CentralHNF
ClinicalTrials.gov Identifier: NCT01375400     History of Changes
Other Study ID Numbers: Aspirin
Study First Received: June 16, 2011
Last Updated: June 20, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Central Hospital, Nancy, France:
aspirin
platelet

Additional relevant MeSH terms:
Ischemia
Stroke
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013