Trial Outcomes & Findings for Validation of an Assay to Measure Cyclooxygenase-1 Activity (NCT NCT00761891)

NCT ID: NCT00761891

Last Updated: 2019-04-18

Results Overview

Determine the level of Thromboxane B2 at which patients with a result above are not fully inhibited, and patients with a TxB2 level below are fully inhibited. The reference range is the level of serum thromboxane at which participants below have fully inhibited COX-1 and participants above do not have fully inhibited COX-1 activity

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 64 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2019-04-18

Participant Flow

Participant milestones

Measure	Chewable Aspirin 81 mg daily for 2 weeks Chewable aspirin: chewable aspirin 81mg daily for 2 weeks
Overall Study STARTED	64
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	Chewable Aspirin 81 mg daily for 2 weeks Chewable aspirin: chewable aspirin 81mg daily for 2 weeks
Overall Study Withdrawal by Subject	10

Baseline Characteristics

Validation of an Assay to Measure Cyclooxygenase-1 Activity

Baseline characteristics by cohort

Measure	Chewable Aspirin n=54 Participants 81 mg daily for 2 weeks Chewable aspirin: chewable aspirin 81mg daily for 2 weeks
Age, Continuous	33.5 years n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	54 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Determine the level of Thromboxane B2 at which patients with a result above are not fully inhibited, and patients with a TxB2 level below are fully inhibited.

The reference range is the level of serum thromboxane at which participants below have fully inhibited COX-1 and participants above do not have fully inhibited COX-1 activity

Outcome measures

Measure	Chewable Aspirin n=54 Participants 81 mg daily for 2 weeks
A Reference Range in Normal Volunteers Taking a Routine Clinical Dose of Aspirin (81mg Daily) for 2 Weeks	13 ng/ml Interval 4.988 to 13.0

SECONDARY outcome

Timeframe: Baseline and at 2 weeks

SerumTxB2: They are formed from the prostaglandin endoperoxides and cause platelet aggregation, contraction of arteries, and other biological effects.

Outcome measures

Measure	Chewable Aspirin n=54 Participants 81 mg daily for 2 weeks
Serum Thromboxane baseline	284.2 ng/ml Standard Error 11.53
Serum Thromboxane 2weeks	9.542 ng/ml Standard Error 0.92

Adverse Events

Enteric-coated 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

Olivier Boutaud, PhD

Department of Pharmacology, School of Medicine, Vanderbilt University

Phone: 615-343-7398

Email: olivier.boutaud@vanderbilt.edu

Results disclosure agreements

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