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OpenTrials
Completed

NCT Number: NCT01586975

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Infarctions Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-None

Treatment and study plan

clopidogrel

Drug

Clopidogrel 75 mg QD

Other names: Plavix

Aspirin 81 mg

Drug

Aspirin 81mg QD

Other names: Acetylsalicylic Acid, ASA

Aspirin >300 mg

Drug

Aspirin >300 mg QD

Other names: Acetylsalicylic Acid, ASA

Primary outcomes

  1. 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."

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Multiphase Study to Determine if Platelet Function Analysis Results Correlate With Ischemic Events and Bleeding Complications

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Apr 27, 2012
Registry last updated
Dec 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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