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Trial Outcomes & Findings for Aspirin Resistance in Coronary Artery Disease (NCT NCT00753935)

NCT ID: NCT00753935

Last Updated: 2018-04-19

Results Overview

Thromboxane A2, the major product of cyclooxygenase cytochrome oxidase (COX-1) in platelets, induces platelet aggregation. Thromboxane B2 is an inactive metabolite/product of thromboxane A2. This primary outcome measures the extent of inhibition of platelet COX-1 by measuring the amount of the metabolite thromboxane B2 in serum.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

92 participants

Primary outcome timeframe

after 2 weeks on aspirin

Results posted on

2018-04-19

Participant Flow

Participant milestones

Participant milestones
Measure
Enteric-coated Aspirin
patients received enteric-coated aspirin 81 mg qd for 2 weeks enteric-coated aspirin: enteric-coated aspirin 81mg daily for 2 weeks
Chewable Aspirin
Patients received chewable aspirin 81 mg qd for 2 weeks Chewable aspirin: chewable aspirin 81mg daily for 2 weeks
Overall Study
STARTED
45
47
Overall Study
COMPLETED
45
47
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aspirin Resistance in Coronary Artery Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Enteric-coated Aspirin
n=45 Participants
patients with coronary artery disease received enteric-coated aspirin 81 mg qd for 2 weeks
Chewable Aspirin
n=47 Participants
Patients with coronary artery disease received chewable aspirin 81 mg qd for 2 weeks
Total
n=92 Participants
Total of all reporting groups
Age, Continuous
62 years
n=5 Participants
68 years
n=7 Participants
65 years
n=5 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
14 Participants
n=7 Participants
26 Participants
n=5 Participants
Sex: Female, Male
Male
33 Participants
n=5 Participants
33 Participants
n=7 Participants
66 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
8 Participants
n=5 Participants
4 Participants
n=7 Participants
12 Participants
n=5 Participants
Race (NIH/OMB)
White
36 Participants
n=5 Participants
42 Participants
n=7 Participants
78 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Region of Enrollment
United States
45 participants
n=5 Participants
47 participants
n=7 Participants
92 participants
n=5 Participants

PRIMARY outcome

Timeframe: after 2 weeks on aspirin

Thromboxane A2, the major product of cyclooxygenase cytochrome oxidase (COX-1) in platelets, induces platelet aggregation. Thromboxane B2 is an inactive metabolite/product of thromboxane A2. This primary outcome measures the extent of inhibition of platelet COX-1 by measuring the amount of the metabolite thromboxane B2 in serum.

Outcome measures

Outcome measures
Measure
Enteric-coated Aspirin
n=45 Participants
patients received enteric-coated aspirin 81 mg qd for 2 weeks enteric-coated aspirin: enteric-coated aspirin 81mg daily for 2 weeks
Chewable Aspirin
n=47 Participants
Patients received chewable aspirin 81 mg qd for 2 weeks Chewable aspirin: chewable aspirin 81mg daily for 2 weeks
Change in Serum Thromboxane B2
5.02 ng/mL
Interval 3.36 to 7.86
2.78 ng/mL
Interval 1.6 to 4.76

Adverse Events

Enteric-coated Aspirin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Chewable 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

John A. Oates, MD

Vanderbilt_University MC

Phone: 615 4343 4847

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place