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

Northwestern University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Stroke; Myocardial Infarctions

Treatments: Drug: Clopidogrel; Drug: Aspirin >300 mg; Drug: Aspirin 81 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01586975

Aspirin Resistance and Stroke

IRB#0996-007 FUND#7810 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

-None

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 3 patient groups

Clopidogrel 75 mg

Active Comparator group

Description:

Clopidogrel 75 mg daily

Treatment:

Drug: Clopidogrel

Aspirin 81 mg

Active Comparator group

Description:

open-label Aspirin 81 mg daily

Treatment:

Drug: Aspirin 81 mg

Aspirin > 300mg

Active Comparator group

Description:

open-label Aspirin over 300 mg daily

Treatment:

Drug: Aspirin >300 mg