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Moderate Alcohol and Cardiovascular Health Trial (MACH15)

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ClinicalTrials.gov Identifier: NCT03169530
Recruitment Status : Terminated (NIH decision)
First Posted : May 30, 2017
Results First Posted : January 30, 2019
Last Update Posted : March 15, 2019
Sponsor:
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
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
Hide 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
Arm/Group Title Alcohol Abstention Total
Hide 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
Hide 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
1.Primary Outcome
Title Cardiovascular Disease or Death
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Time from baseline to cardiovascular mortality.
Time Frame Every 3 months for 90 months or closeout, or date of death
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Progression among normoglycemic individuals to ADA-defined pre-diabetes.
Time Frame Every 12 months for 90 months or closeout
Hide Outcome Measure Data
Hide 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
Hide 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.
Time Frame 5 months; from first enrolled subject until study termination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alcohol Abstention
Hide 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%) 
Hide Serious Adverse Events
Alcohol Abstention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/17 (0.00%) 
Hide 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%) 
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
Layout table for Results Point of Contact information
Name/Title: Kenneth Mukamal, MD, MPH
Organization: Beth Israel Deaconess Medical Center
Phone: 617 754-1401
EMail: kmukamal@bidmc.harvard.edu
Layout table for additonal information
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