Multiphase Study to Determine if Platelet Function Analysis Results Correlate With Ischemic Events and Bleeding Complications
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- PFA1
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient must be taking Aspirin or Plavix
- •Patient must have had a stroke, TIA or cerebrovascular disease
Exclusion Criteria
- Not provided
Arms & Interventions
Aspirin > 300mg
open-label Aspirin over 300 mg daily
Intervention: Aspirin >300 mg (Drug)
Aspirin 81 mg
open-label Aspirin 81 mg daily
Intervention: Aspirin 81 mg (Drug)
Clopidogrel 75 mg
Clopidogrel 75 mg daily
Intervention: Clopidogrel (Drug)
Outcomes
Primary Outcomes
PFA1
Time Frame: 3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months)
Platelet Function Analysis (PFA) lab results: PFA was performed using the PFA 100 device (Dade-Behring), which uses a higher sheer stress flow cytometry paradigm to measure the time in seconds to closing of an aperture. Normal is defined as \<172 seconds."
Secondary Outcomes
No secondary outcomes reported