NCT01375400

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2011

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Last Updated

June 21, 2011

Status Verified

June 1, 2011

Enrollment Period

7 months

First QC Date

June 16, 2011

Last Update Submit

June 20, 2011

Conditions

Keywords

aspirinplatelet

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

    1 month

Interventions

Administration of 300 mg of aspirin, per os.

blood sampleBIOLOGICAL

2 blood samples will be performed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital central

Nancy, 54035, France

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

AspirinBlood Specimen Collection

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Sébastien Richard, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 17, 2011

Study Start

December 1, 2010

Primary Completion

July 1, 2011

Last Updated

June 21, 2011

Record last verified: 2011-06

Locations