Trial Outcomes & Findings for Aspirin Dose and Atherosclerosis in Patients With Metabolic Syndrome (NCT NCT00272311)

Results Overview

Changes in Heme oxygenase (HO-1) a downstream target of nitric oxide (NO) formation.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

70 participants

Primary outcome timeframe

Baseline to 3 Months (90-97 days)

Results posted on

2019-02-27

Participant Flow

From Dec 2006 through May 2007, 70 eligible subjects were randomized from a primary care clinical site under the direction of Alex Pokov, MD.

In this trial there was no wash-out or run-in period, as all eligible subjects were not taking aspirin.

Participant milestones

Participant milestones
Measure	Arm 1 of 5 Randomized Treatment Arms 81 mg Aspirin	Arm 2 of 5 Randomized Treatment Arms 162 mg Aspirin	Arm 3 of 5 Randomized Treatment Arms 325 mg Aspirin	Arm 4 of 5 Randomized Treatment Arms 650 mg Aspirin	Arm 5 of 5 Randomized Treatment Arms 1300 mg Aspirin
Overall Study STARTED	14	14	14	14	14
Overall Study COMPLETED	14	14	14	14	14
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 Metabolic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 of 5 Randomized Treatment Arms n=14 Participants 81 mg Aspirin	Arm 2 of 5 Randomized Treatment Arms n=14 Participants 162 mg Aspirin	Arm 3 of 5 Randomized Treatment Arms n=14 Participants 325 mg Aspirin	Arm 4 of 5 Randomized Treatment Arms n=14 Participants 650 mg Aspirin	Arm 5 of 5 Randomized Treatment Arms n=14 Participants 1300 mg Aspirin	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	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	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants	8 Participants n=21 Participants	51 Participants n=8 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	19 Participants n=8 Participants
Age, Continuous	58.3 years STANDARD_DEVIATION 10.3 • n=5 Participants	57.0 years STANDARD_DEVIATION 10.0 • n=7 Participants	55.5 years STANDARD_DEVIATION 9.2 • n=5 Participants	58.0 years STANDARD_DEVIATION 9.6 • n=4 Participants	59.1 years STANDARD_DEVIATION 11.4 • n=21 Participants	57.6 years STANDARD_DEVIATION 9.9 • n=8 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	10 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	9 Participants n=21 Participants	33 Participants n=8 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	5 Participants n=21 Participants	37 Participants n=8 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	14 participants n=5 Participants	14 participants n=4 Participants	14 participants n=21 Participants	70 participants n=8 Participants

PRIMARY outcome

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

Population: Complete baseline and follow-up data

Changes in Heme oxygenase (HO-1) a downstream target of nitric oxide (NO) formation.

Outcome measures

Outcome measures
Measure	Arm 1 of 5 Randomized Treatment Arms n=14 Participants 81 mg Aspirin	Arm 2 of 5 Randomized Treatment Arms n=11 Participants 162 mg Aspirin	Arm 3 of 5 Randomized Treatment Arms n=12 Participants 325 mg Aspirin	Arm 4 of 5 Randomized Treatment Arms n=10 Participants 650 mg Aspirin	Arm 5 of 5 Randomized Treatment Arms n=13 Participants 1300 mg Aspirin
Change in Nitric Oxide Formation From Baseline to 3 Months	27.6 ng/mL Standard Deviation 4.9	27.0 ng/mL Standard Deviation 4.4	31.4 ng/mL Standard Deviation 9.8	25.7 ng/mL Standard Deviation 3.4	28.3 ng/mL Standard Deviation 4.1

OTHER_PRE_SPECIFIED outcome

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

Population: At the end of the study, due to lack of funds, analysis of this outcome was not conducted.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

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

Population: At the end of the study due to lack of funds analysis of this data was not conducted.