Trial Outcomes & Findings for Moderate Alcohol and Cardiovascular Health Trial (NCT 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.

Recruitment status

TERMINATED

Study phase

Target enrollment

103 participants

Primary outcome timeframe

Every 3 months for up to 90 months or close out, or until date of death

Results posted on

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

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

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

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=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Age, Continuous	73.5 Years STANDARD_DEVIATION 8.7 • n=5 Participants	68.5 Years STANDARD_DEVIATION 10.3 • n=7 Participants	70.8 Years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Netherlands	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants
Region of Enrollment Nigeria	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 3 months for up to 90 months or close out, or until date of death

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 3 months for up to 90 months or close out, or until date of death

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 12 months for 90 months or close out, or until date of first documented occurence

Population: 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 death

Population: 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 death

Population: 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 death

Time from baseline to cardiovascular mortality.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Every 12 months for 90 months or closeout

Population: 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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Abstention

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

Kenneth Mukamal, MD, MPH

Beth Israel Deaconess Medical Center

Phone: 617 754-1401

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place