Genotypic and Phenotypic Correlates of Resistance to Aspirin

Not Applicable

Completed

• Conditions: Platelet Dysfunction Due to Aspirin
• Interventions: Drug: aspirin

• Registration Number: NCT01361620
• Lead Sponsor: George Washington University

Brief Summary

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

Detailed Description

Not desired

Study Timeline

• Study Start: 2007-12
• Status Verified: 2011-01
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2011-05-25
• Study First Submitted QC: 2011-05-26
• Study First Posted: 2011-05-27
• Results First Submitted: 2013-08-19
• Results First Submitted QC: 2013-10-29
• Last Update Submitted: 2013-10-29
• Results First Posted: 2013-12-16
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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,
  • heparin,
  • NSAIDs (except aspirin),
  • clopidogrel,
  • dipyridamole,
  • fish-oil/omega 3 supplements,

• Women of childbearing potential who are pregnant, planning to become pregnant or nursing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aspirin	aspirin	All subjects took 7-10 days of 81 mg aspirin

Primary Outcome Measures

Name	Time	Method
Whole Blood Coagulation	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.

Trial Locations

Locations (1)

GWU Medical Faculty Associates; 🇺🇸 Washington, District of Columbia, United States