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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01586975
• Other study ID #: Aspirin Resistance and Stroke
• Secondary ID: IRB#0996-007 FUN
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 3, 2011
• Last updated: December 2, 2015
• Start date: July 2007
• Est. completion date: December 2011

Study information

• Verified date: December 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient must be taking Aspirin or Plavix

• Patient must have had a stroke, TIA or cerebrovascular disease

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myocardial Infarction
• Myocardial Infarctions
• Stroke

Intervention

Drug:
• Clopidogrel
Clopidogrel 75 mg QD
• Aspirin 81 mg
Aspirin 81mg QD
• Aspirin >300 mg
Aspirin >300 mg QD

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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."	3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months)	Yes