Trial Outcomes & Findings for Aspirin Dose and Atherosclerosis in Patients With Heart Disease (NCT NCT00272337)

Results Overview

Heme oxygenase a downstream target of nitric oxide formation

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

37 participants

Primary outcome timeframe

Baseline to 3 Months (90-97 days)

Results posted on

2018-12-28

Participant Flow

37 subjects were enrolled. Recruitment began in November 2006 and completed in July 2007 in two cardiology office practices directed by Ricky Schneider M.D. and Steven Borzak M.D.

This trial did not include a wash-out or run-in period.

Participant milestones

Participant milestones
Measure	1 of 5 Randomized Treatment Arms 81 mg Aspirin	2 of 5 Randomized Treatment Arms 162 mg Aspirin	3 of 5 Randomized Treatment Arms 325 mg Aspirin	4 of 5 Randomized Treatment Arms 650 mg Aspirin	5 of 5 Randomized Treatment Arms 1300 mg Aspirin
Overall Study STARTED	8	7	7	7	8
Overall Study COMPLETED	8	7	7	7	8
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aspirin Dose and Atherosclerosis in Patients With Heart Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=37 Participants Total of all reporting groups	1 of 5 Randomized Treatment Arms n=8 Participants 81 mg Aspirin	2 of 5 Randomized Treatment Arms n=7 Participants 162 mg Aspirin	3 of 5 Randomized Treatment Arms n=7 Participants 325 mg Aspirin	4 of 5 Randomized Treatment Arms n=7 Participants 650 mg Aspirin	5 of 5 Randomized Treatment Arms n=8 Participants 1300 mg Aspirin
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=10 Participants	5 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants
Age, Categorical >=65 years	16 Participants n=10 Participants	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants
Age, Continuous	64.0 years STANDARD_DEVIATION 8.9 • n=10 Participants	61.8 years STANDARD_DEVIATION 9.7 • n=5 Participants	67.8 years STANDARD_DEVIATION 8.0 • n=7 Participants	61.2 years STANDARD_DEVIATION 9.0 • n=5 Participants	67.2 years STANDARD_DEVIATION 6.0 • n=4 Participants	62.6 years STANDARD_DEVIATION 10.8 • n=21 Participants
Sex: Female, Male Female	12 Participants n=10 Participants	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants
Sex: Female, Male Male	25 Participants n=10 Participants	7 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment United States	37 participants n=10 Participants	8 participants n=5 Participants	7 participants n=7 Participants	7 participants n=5 Participants	7 participants n=4 Participants	8 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline to 3 Months (90-97 days)

Population: Complete baseline and follow-up data

Heme oxygenase a downstream target of nitric oxide formation

Outcome measures

Outcome measures
Measure	1 of 5 Randomized Treatment Arms n=8 Participants 81 mg Aspirin	2 of 5 Randomized Treatment Arms n=6 Participants 162 mg Aspirin	3 of 5 Randomized Treatment Arms n=7 Participants 325 mg Aspirin	4 of 5 Randomized Treatment Arms n=6 Participants 650 mg Aspirin	5 of 5 Randomized Treatment Arms n=8 Participants 1300 mg Aspirin
Change in Nitric Oxide Formation From Baseline to 3 Months.	10.0 ng/mL Standard Deviation 4.1	11.2 ng/mL Standard Deviation 2.8	10.0 ng/mL Standard Deviation 2.3	11.0 ng/mL Standard Deviation 1.7	9.6 ng/mL Standard Deviation 3.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 3 Months (90-97 days)

Population: At the conclusion of the trial in 2010, due to lack of funds for analysis, analysis was not conducted.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 3 Months (90-97 days)

Population: At the conclusion of the trial in 2010, due to lack of funds for analysis, analysis was not conducted.