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

December 2, 2015 updated by: Northwestern University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clopidogrel 75 mg
Clopidogrel 75 mg daily
Drug: Clopidogrel
Clopidogrel 75 mg QD
Other Names:
  • Plavix
Active Comparator: Aspirin 81 mg
open-label Aspirin 81 mg daily
Drug: Aspirin 81 mg
Aspirin 81mg QD
Other Names:
  • Acetylsalicylic Acid
  • ASA
Active Comparator: Aspirin > 300mg
open-label Aspirin over 300 mg daily
Drug: Aspirin >300 mg
Aspirin >300 mg QD
Other Names:
  • Acetylsalicylic Acid
  • ASA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Mark J Alberts, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 3, 2011

First Submitted That Met QC Criteria

April 26, 2012

First Posted (Estimate)

April 27, 2012

Study Record Updates

Last Update Posted (Estimate)

December 31, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aspirin Resistance and Stroke
  • IRB#0996-007 FUND#7810 (Other Identifier: Northwestern Memorial Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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