Trial Outcomes & Findings for Genotypic and Phenotypic Correlates of Resistance to Aspirin (NCT NCT01361620)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

190 participants

Primary outcome timeframe

Single measurement at 7-10 days after beginning aspirin

Results posted on

2013-12-16

Participant Flow

Subjects were recruited from patients of the GWU Medical Faculty Associates, and physicians, faculty and staff on the GWU campus. Initially we were looking for those already prescribed to take aspirin at 81 mg daily, but due to slow recruitment, this was amended to anyone willing to take aspirin at 81 mg daily for 7-10 days

Excluded were 58 subjects prescribed more than 81 mg of aspirin, had known GI bleeding attributed to aspirin, active peptic ulcer disease, aspirin allergy, current use of other anti-platelet, anti-thrombotic or other therapy that has these properties, women who are pregnant, planning pregnancy or nursing. Exclusions were for safety reasons.

Participant milestones

Participant milestones
Measure	Aspirin All subjects took 7-10 days of 81 mg aspirin
Overall Study STARTED	132
Overall Study COMPLETED	132
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Genotypic and Phenotypic Correlates of Resistance to Aspirin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aspirin n=132 Participants All subjects took 7-10 days of 81 mg aspirin
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	91 Participants n=5 Participants
Age, Categorical >=65 years	41 Participants n=5 Participants
Age Continuous	61 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants
Region of Enrollment United States	132 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Aspirin n=132 Participants All subjects took 7-10 days of 81 mg aspirin
Whole Blood Coagulation	453.8 Aspirin response units (ARU) Standard Deviation 51.9

Adverse Events

Aspirin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Timothy McCaffrey

George Washington University

Phone: (202) 994-8919

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place