Aspirin Resistance and Stroke Risk: Platelet Function Analysis in Patients With Ischemic Events

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to determine if PFA results correlate with ischemic event outcomes as well as bleeding complications. Hypothesis is antiplatelet agents will be more efficacious if they are administered in a dose-adjusted manner using PFA results as a guide.

Detailed Description

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Atherothrombotic disease is a leading killer of adults throughout the world. The current mainstay for the prevention of ischemic vascular events is the use of aspirin Antiplatelet agents are used routinely for the primary and secondary prevention of vascular events in patients with a prior history of stroke, TIA, or at high risk for the development of cerebrovascular disease. Numberous individual studies and meta-analyses have shown that essentially all of the oral antiplatelet agents have limited efficacy, with relative risk reductions in the range of 20-35%. The purpose of this study is to perform serial platelet function assays (PFAs) on patients with cerebrovascular disease who are taking antiplatelet agents and perform a pilot study to determine the feasibility of administering ASA as a dose adjusted medication using PFA. The long term goal of this study is to determine whether antiplatelet therapy will be more efficacious and/or safer if it is administered in a dose-adjusted manner.

Conditions

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Stroke Myocardial Infarctions

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clopidogrel 75 mg

Clopidogrel 75 mg daily

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Clopidogrel 75 mg QD

Aspirin 81 mg

open-label Aspirin 81 mg daily

Group Type ACTIVE_COMPARATOR

Aspirin 81 mg

Intervention Type DRUG

Aspirin 81mg QD

Aspirin > 300mg

open-label Aspirin over 300 mg daily

Group Type ACTIVE_COMPARATOR

Aspirin >300 mg

Intervention Type DRUG

Aspirin \>300 mg QD

Interventions

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Clopidogrel

Clopidogrel 75 mg QD

Intervention Type DRUG

Aspirin 81 mg

Aspirin 81mg QD

Intervention Type DRUG

Aspirin >300 mg

Aspirin \>300 mg QD

Intervention Type DRUG

Other Intervention Names

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Plavix Acetylsalicylic Acid ASA Acetylsalicylic Acid ASA

Eligibility Criteria

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Inclusion Criteria

* Patient must be taking Aspirin or Plavix
* Patient must have had a stroke, TIA or cerebrovascular disease

Exclusion Criteria

-None

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark J Alberts, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Taylor TN, Davis PH, Torner JC, Holmes J, Meyer JW, Jacobson MF. Lifetime cost of stroke in the United States. Stroke. 1996 Sep;27(9):1459-66. doi: 10.1161/01.str.27.9.1459.

Reference Type BACKGROUND

PMID: 8784113 (View on PubMed)

Other Identifiers

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IRB#0996-007 FUND#7810

Identifier Type: OTHER

Identifier Source: secondary_id