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

Primary Purpose

Stroke, Myocardial Infarctions

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Clopidogrel

Aspirin 81 mg

Aspirin >300 mg

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-None

Sites / Locations

Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Clopidogrel 75 mg

Aspirin 81 mg

Aspirin > 300mg

Arm Description

Clopidogrel 75 mg daily

open-label Aspirin 81 mg daily

open-label Aspirin over 300 mg daily

Outcomes

Primary Outcome Measures

PFA1

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 Outcome Measures

Full Information

NCT ID

NCT01586975

First Posted

August 3, 2011

Last Updated

December 2, 2015

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT01586975

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northwestern University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Myocardial Infarctions

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clopidogrel 75 mg

Arm Type

Active Comparator

Arm Description

Clopidogrel 75 mg daily

Arm Title

Aspirin 81 mg

Arm Type

Active Comparator

Arm Description

open-label Aspirin 81 mg daily

Arm Title

Aspirin > 300mg

Arm Type

Active Comparator

Arm Description

open-label Aspirin over 300 mg daily

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Other Intervention Name(s)

Plavix

Intervention Description

Clopidogrel 75 mg QD

Intervention Type

Drug

Intervention Name(s)

Aspirin 81 mg

Other Intervention Name(s)

Acetylsalicylic Acid, ASA

Intervention Description

Aspirin 81mg QD

Intervention Type

Drug

Intervention Name(s)

Aspirin >300 mg

Other Intervention Name(s)

Acetylsalicylic Acid, ASA

Intervention Description

Aspirin >300 mg QD

Primary Outcome Measure Information:

Title

PFA1

Description

Time Frame

3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient must be taking Aspirin or Plavix Patient must have had a stroke, TIA or cerebrovascular disease Exclusion Criteria: -None

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark J Alberts, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

8784113

Citation

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.

Results Reference

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

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