Moderate Alcohol and Cardiovascular Health Trial (MACH15)

• ClinicalTrials.gov Identifier: NCT03169530
• Recruitment Status: Terminated
• First Posted: May 30, 2017
• Results First Posted: January 30, 2019
• Last Update Posted: March 15, 2019
• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); Harvard School of Public Health (HSPH); Wake Forest University Health Sciences; Julius Center
• Information provided by (Responsible Party): Kenneth Mukamal, Beth Israel Deaconess Medical Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
• Conditions: Cardiovascular Diseases; Diabetes
• Intervention: Other: Alcohol
• Enrollment: 103

Participant Flow

Recruitment Details	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.
Pre-assignment Details	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.

Arm/Group Title	Alcohol	Abstention
Arm/Group Description	One standard serving of alcohol (~15 gm) daily Alcohol: ~15 gm daily of beer, wine, or spirits for ~6 years	Abstention from alcohol
Period Title: Overall Study
Started	15	17
Completed	0	0
Not Completed	15	17
Reason Not Completed
Study ended by NIH	15	17

Baseline Characteristics

Arm/Group Title		Alcohol	Abstention	Total
Arm/Group Description		One standard serving of alcohol (~15 gm) daily Alcohol: ~15 gm daily of beer, wine, or spirits for ~6 years	Abstention from alcohol	Total of all reporting groups
Overall Number of Baseline Participants		15	17	32
Baseline Analysis Population Description		All randomized participants
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	17 participants	32 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	1 6.7%	7 41.2%	8 25.0%
	>=65 years	14 93.3%	10 58.8%	24 75.0%
Age, Continuous [1]; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	15 participants	17 participants	32 participants
		73.5 (8.7)	68.5 (10.3)	70.8 (9.8)
		[1] Measure Description: All Randomized Participants
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	17 participants	32 participants
	Female	7 46.7%	7 41.2%	14 43.8%
	Male	8 53.3%	10 58.8%	18 56.3%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	17 participants	32 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	15 100.0%	17 100.0%	32 100.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	17 participants	32 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	6 40.0%	10 58.8%	16 50.0%
	White	8 53.3%	7 41.2%	15 46.9%
	More than one race	1 6.7%	0 0.0%	1 3.1%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	15 participants	17 participants	32 participants
Netherlands		0	1	1
United States		11	11	22
Nigeria		4	5	9

Outcome Measures

1. Primary Outcome

Title	Cardiovascular Disease or Death
Description	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.
Time Frame	Every 3 months for up to 90 months or close out, or until date of death

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Alcohol	Abstention
Arm/Group Description:	One standard serving of alcohol (~15 gm) daily Alcohol: ~15 gm daily of beer, wine, or spirits for ~6 years	Abstention from alcohol
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

2. Secondary Outcome

Title	Cardiovascular Disease
Description	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.
Time Frame	Every 3 months for up to 90 months or close out, or until date of death

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Alcohol	Abstention
Arm/Group Description:	One standard serving of alcohol (~15 gm) daily Alcohol: ~15 gm daily of beer, wine, or spirits for ~6 years	Abstention from alcohol
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

3. Secondary Outcome

Title	Diabetes
Description	Progression among normoglycemic and pre-diabetes individuals to American Diabetes Association (ADA)-defined diabetes.
Time Frame	Every 12 months for 90 months or close out, or until date of first documented occurence

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Alcohol	Abstention
Arm/Group Description:	One standard serving of alcohol (~15 gm) daily Alcohol: ~15 gm daily of beer, wine, or spirits for ~6 years	Abstention from alcohol
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

4. Other Pre-specified Outcome

Title	Hard Cardiovascular Disease or Death
Description	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.
Time Frame	Every 3 months for 90 month or close out, or until date of death

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Alcohol	Abstention
Arm/Group Description:	One standard serving of alcohol (~15 gm) daily Alcohol: ~15 gm daily of beer, wine, or spirits for ~6 years	Abstention from alcohol
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

5. Other Pre-specified Outcome

Title	Components of Primary Composite Endpoint
Description	Time from baseline to the first occurrence of each of the components of primary outcome (5 outcomes).
Time Frame	Every 3 months for up to 90 months or close out, or until date of death

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Alcohol	Abstention
Arm/Group Description:	One standard serving of alcohol (~15 gm) daily Alcohol: ~15 gm daily of beer, wine, or spirits for ~6 years	Abstention from alcohol
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

6. Other Pre-specified Outcome

Title	Cardiovascular Death
Description	Time from baseline to cardiovascular mortality.
Time Frame	Every 3 months for 90 months or closeout, or date of death

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Alcohol	Abstention
Arm/Group Description:	One standard serving of alcohol (~15 gm) daily Alcohol: ~15 gm daily of beer, wine, or spirits for ~6 years	Abstention from alcohol
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

7. Other Pre-specified Outcome

Title	Pre-Diabetes
Description	Progression among normoglycemic individuals to ADA-defined pre-diabetes.
Time Frame	Every 12 months for 90 months or closeout

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Alcohol	Abstention
Arm/Group Description:	One standard serving of alcohol (~15 gm) daily Alcohol: ~15 gm daily of beer, wine, or spirits for ~6 years	Abstention from alcohol
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	5 months; from first enrolled subject until study termination.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Alcohol	Abstention
Arm/Group Description	One standard serving of alcohol (~15 gm) daily Alcohol: ~15 gm daily of beer, wine, or spirits for ~6 years	Abstention from alcohol
All-Cause Mortality
	Alcohol	Abstention
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/15 (0.00%)	0/17 (0.00%)
Serious Adverse Events
	Alcohol	Abstention
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/15 (0.00%)	0/17 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Alcohol	Abstention
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/15 (0.00%)	0/17 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Kenneth Mukamal, MD, MPH
• Organization: Beth Israel Deaconess Medical Center
• Phone: 617 754-1401
• EMail: kmukamal@bidmc.harvard.edu

Publications:

Mukamal KJ, Clowry CM, Murray MM, Hendriks HF, Rimm EB, Sink KM, Adebamowo CA, Dragsted LO, Lapinski PS, Lazo M, Krystal JH. Moderate Alcohol Consumption and Chronic Disease: The Case for a Long-Term Trial. Alcohol Clin Exp Res. 2016 Nov;40(11):2283-2291. doi: 10.1111/acer.13231. Epub 2016 Sep 30. Review.

• Responsible Party: Kenneth Mukamal, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT03169530
• Other Study ID Numbers: 2017P000333; U10AA025286 ( U.S. NIH Grant/Contract )
• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Results First Submitted: November 30, 2018
• Results First Posted: January 30, 2019
• Last Update Posted: March 15, 2019