Genotypic and Phenotypic Correlates of Resistance to Anti-platelet Actions of Aspirin in an At-risk Patient Population and in the General Population

George Washington University1 site in 1 country190 target enrollmentDecember 2007

ConditionsPlatelet Dysfunction Due to Aspirin

Interventionsaspirin

Drugsaspirin

Overview

Phase: Not Applicable
Intervention: aspirin
Conditions: Platelet Dysfunction Due to Aspirin
Sponsor: George Washington University
Enrollment: 190
Locations: 1
Primary Endpoint: Whole Blood Coagulation
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study seeks to identify genomic markers associated with aspirin resistance.

Detailed Description

Not desired

Registry

clinicaltrials.gov

Start Date

December 2007

End Date

April 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

George Washington University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Volunteers 40 to 80 years old willing to sign consent and take 81 mg of aspirin for 7 - 10 days and return for laboratory testing.

Exclusion Criteria

•Patient requiring more than 81 mg aspirin daily
•Known GI bleeding attributed to ASA
•Active peptic ulcer disease or history within the last year
•Known aspirin allergy
•Current use of:
•warfarin,
•NSAIDs (except aspirin),
•clopidogrel,
•dipyridamole,
•fish-oil/omega 3 supplements,

Arms & Interventions

Aspirin

All subjects took 7-10 days of 81 mg aspirin

Intervention: aspirin

Outcomes

Primary Outcomes

Whole Blood Coagulation

Time Frame: Single measurement at 7-10 days after beginning aspirin

Whole blood coagulation after stimulation with arachidonic acid, as measured in the VerifyNow Aspirin system (Accumetrics). Aspirin response units (ARU) are the residual coagulation present in patients taking aspirin. The higher the ARU, the greater residual coagulation (resistance) to the aspirin effect.