Trial Outcomes & Findings for Moderate Alcohol and Cardiovascular Health Trial (NCT NCT03169530)
NCT ID: NCT03169530
Last Updated: 2019-03-15
Results Overview
Time from baseline to a composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization for angina, coronary/carotid revascularization, or all-cause mortality.
TERMINATED
NA
103 participants
Every 3 months for up to 90 months or close out, or until date of death
2019-03-15
Participant Flow
103 subjects provided signed consent, 32 subjects were randomized. The additional 71 subjects were in the screening or in the run-in stage of the trial at the time of study cessation.
103 subjects provided signed consent, 32 subjects were randomized. The additional 71 subjects were in the screening or run-in stages of the trial at the time of study cessation.
Participant milestones
| Measure |
Alcohol
One standard serving of alcohol (\~15 gm) daily
Alcohol: \~15 gm daily of beer, wine, or spirits for \~6 years
|
Abstention
Abstention from alcohol
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
17
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
17
|
Reasons for withdrawal
| Measure |
Alcohol
One standard serving of alcohol (\~15 gm) daily
Alcohol: \~15 gm daily of beer, wine, or spirits for \~6 years
|
Abstention
Abstention from alcohol
|
|---|---|---|
|
Overall Study
Study ended by NIH
|
15
|
17
|
Baseline Characteristics
Moderate Alcohol and Cardiovascular Health Trial
Baseline characteristics by cohort
| Measure |
Alcohol
n=15 Participants
One standard serving of alcohol (\~15 gm) daily
Alcohol: \~15 gm daily of beer, wine, or spirits for \~6 years
|
Abstention
n=17 Participants
Abstention from alcohol
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Continuous
|
73.5 Years
STANDARD_DEVIATION 8.7 • n=99 Participants
|
68.5 Years
STANDARD_DEVIATION 10.3 • n=107 Participants
|
70.8 Years
STANDARD_DEVIATION 9.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
11 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Region of Enrollment
Nigeria
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Every 3 months for up to 90 months or close out, or until date of deathPopulation: The trial was closed prior to any subject competing a 3-month visit, precluding assessment of the primary outcome. Therefore, no data for the CV disease outcome were collected or analyzed prior to study termination. No subjects died during the trial.
Time from baseline to a composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization for angina, coronary/carotid revascularization, or all-cause mortality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 3 months for up to 90 months or close out, or until date of deathPopulation: The trial was closed prior to any subject competing a 3-month visit, precluding assessment of this secondary outcome. Therefore, no data for this outcome were collected or analyzed prior to study termination. No subjects died during the trial.
Time from baseline to a composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization for angina, coronary/carotid revascularization, or cardiovascular mortality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 12 months for 90 months or close out, or until date of first documented occurencePopulation: The trial was closed prior to any subject competing a 12-month visit, precluding assessment of this outcome. Therefore, no data for the diabetes outcome were collected or analyzed prior to study termination.
Progression among normoglycemic and pre-diabetes individuals to American Diabetes Association (ADA)-defined diabetes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Every 3 months for 90 month or close out, or until date of deathPopulation: The trial was closed prior to any subject competing a 3-month visit, precluding assessment of this outcome. Therefore, no data for this outcome were collected or analyzed prior to study termination. No subjects died during the trial.
Time from baseline to a composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, or cardiovascular death.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Every 3 months for up to 90 months or close out, or until date of deathPopulation: The trial was closed prior to any subject competing a 3-month visit, precluding assessment of these outcomes. Therefore, no data were collected or analyzed prior to study termination. No subjects died during the trial.
Time from baseline to the first occurrence of each of the components of primary outcome (5 outcomes).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Every 3 months for 90 months or closeout, or date of deathPopulation: The trial was closed prior to any subject competing a 3-month visit, precluding assessment of this outcome. Therefore, no data for this outcome were collected or analyzed prior to study termination. No subjects died prior to completion of a 3-month visit.
Time from baseline to cardiovascular mortality.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Every 12 months for 90 months or closeoutPopulation: The trial was closed prior to any subject competing a 12-month visit, precluding assessment of this outcome. Therefore, no data for this outcome were collected or analyzed prior to study termination.
Progression among normoglycemic individuals to ADA-defined pre-diabetes.
Outcome measures
Outcome data not reported
Adverse Events
Alcohol
Abstention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kenneth Mukamal, MD, MPH
Beth Israel Deaconess Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place