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Moderate Alcohol and Cardiovascular Health Trial (MACH15)

This study is not yet open for participant recruitment.
Verified December 2017 by Kenneth Mukamal, Beth Israel Deaconess Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03169530
First Posted: May 30, 2017
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Harvard School of Public Health
Wake Forest University Health Sciences
Julius Center
Information provided by (Responsible Party):
Kenneth Mukamal, Beth Israel Deaconess Medical Center
  Purpose
The Moderate Alcohol and Cardiovascular Health Trial (MACH15) is a multicenter, worldwide, randomized clinical trial of ~15 gm of alcohol daily versus abstention, using a balanced parallel design and single-blind assessment of all outcomes among approximately 7,800 participants aged 50 years and older with advanced cardiovascular risk. Intervention will average 6 years in duration with a common close-out date. Following recruitment and pre-screening, participants will attend a screening visit followed by a two-week abstention washout period, a baseline visit and randomization, and subsequent visits at 3 months, 6 months, 12 months, and then annually until close-out.

Condition Intervention
Cardiovascular Diseases Diabetes Other: Alcohol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Balanced-design randomized trial, comparing the effects of one standard serving (~15 grams) of alcohol intake daily to abstention.
Masking: Single (Outcomes Assessor)
Masking Description:
Clinical outcome events will be assessed through medical record review by a masked Medical Safety Officer (MSO).
Primary Purpose: Prevention
Official Title: Moderate Alcohol and Cardiovascular Health Trial

Further study details as provided by Kenneth Mukamal, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Cardiovascular Disease or Death [ Time Frame: Every 3 months for up to 90 months or close out, or until date of death ]
    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.


Secondary Outcome Measures:
  • Cardiovascular Disease [ Time Frame: Every 3 months for up to 90 months or close out, or until date of death ]
    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.

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


Other Outcome Measures:
  • Hard Cardiovascular Disease or Death [ Time Frame: Every 3 months for 90 month or close out, or until date of death ]
    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.

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

  • Cardiovascular Death [ Time Frame: Every 3 months for 90 months or closeout, or date of death ]
    Time from baseline to cardiovascular mortality.

  • Pre-Diabetes [ Time Frame: Every 12 months for 90 months or closeout ]
    Progression among normoglycemic individuals to ADA-defined pre-diabetes.


Estimated Enrollment: 7800
Anticipated Study Start Date: December 29, 2017
Estimated Study Completion Date: July 31, 2026
Estimated Primary Completion Date: February 28, 2026 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Alcohol
One standard serving of alcohol (~15 gm) daily
Other: Alcohol
~15 gm daily of beer, wine, or spirits for ~6 years
Other Name: ethanol, beer, wine, spirits
No Intervention: Abstention
Abstention from alcohol

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥50 years at screening
  • Postmenopausal, defined as 12 consecutive months without menstruation
  • Not alcohol naïve, defined by having consumed at least one drink of alcohol in the past five years
  • High risk for the occurrence of a new cardiovascular disease event, defined as having any one of the following:

    1. American Heart Association (AHA)/American College of Cardiology (ACC) Risk Score ≥15% within the past 24 months (among those without clinical or subclinical cardiovascular disease [CVD])
    2. Clinical CVD (more than 6 months prior to randomization), defined by:

      1. Previous myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), carotid endarterectomy (CE), carotid stenting;
      2. Peripheral artery disease (PAD) with revascularization;
      3. Acute coronary syndrome with or without resting electrocardiogram (ECG) change, ECG changes on a graded exercise test (GXT), or positive cardiac imaging study;
      4. Prior stroke documented on brain imaging or with a persistent deficit.
    3. Subclinical CVD, confirmed in available medical records:

      1. At least a 50% diameter stenosis of a coronary, carotid, or lower extremity artery;
      2. Coronary artery calcium score ≥400 Agatston units;
      3. Ankle brachial index (ABI) ≤0.90;
      4. Left ventricular hypertrophy (LVH) by ECG (based on computer reading), echocardiogram report, or other cardiac imaging procedure report;
      5. Abdominal aortic aneurysm (AAA) ≥5 cm with or without repair.

Exclusion Criteria:

  • High alcohol consumption, defined by any one of the following:

    1. Alcohol Use Disorders Identification Test (AUDIT) score >5 at screening
    2. Drinking, on average, >7 alcoholic beverages/week during the past 6 months
    3. Drinking 6 or more alcoholic beverages on one occasion during the past 6 months
  • Yale-Brown Obsessive Compulsive Scale-heavy drinking (Y-BOCS-hd) total score of ≥6 on questions 7, 8, and 10
  • Cardiovascular disease event (MI, revascularization procedure, or stroke) within the 6 months prior to randomization
  • AHA Class III-IV heart failure
  • History of alcohol or substance abuse (medical record confirmed or self-reported history)
  • Other intolerance or allergy to alcohol
  • Dual antiplatelet therapy
  • History of gastric bypass surgery
  • Any serious chronic liver disease (e.g., active hepatitis B and C infections) or liver tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT] and gamma-glutamyl transpeptidase [GGT]) >2 times the upper limit of the normal range using local standards
  • Personal history of any colon or liver cancer
  • Any other cancer with a life expectancy of less than 3 years
  • Diagnosed with breast cancer that required either surgery or removal of breast tissue or chemotherapy
  • Mother or sister ever diagnosed with breast cancer that required either surgery or removal of breast tissue or chemotherapy
  • Estimated glomerular filtration rate (eGFR) <30 ml/min /1.73m2 or end-stage renal disease (ESRD)
  • Ongoing use of any medication for which alcohol consumption is contraindicated
  • A Patient Health Questionnaire (PHQ-9) ≥15 at screening
  • History of any organ transplant
  • Unintentional weight loss >10% in last 6 months
  • Currently participating in another clinical trial (intervention trial) with CVD outcomes. Note: Participant must wait until the completion of his/her activities or the completion of the other trial before being screened for MACH15. Local restrictions for entry by participants can be more conservative if mandated.
  • Not willing or able to provide a name and contact information for at least one additional contact person other than self
  • Investigator discretion regarding appropriateness of participation or concern about intervention adherence, including:

    1. moderate - severe psychiatric illness
    2. behavioral concerns regarding likelihood of low adherence to trial protocol
    3. a medical condition likely to limit survival to less than 3 years
    4. advanced chronic disease, such as dementia, that requires 24-hour care
  • Not willing or able to provide a signed and dated informed consent form
  • Not willing or able to comply with all trial procedures.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169530


Contacts
Contact: Stacey M Brown, MS (617) 754-1462 smbrown@bidmc.harvard.edu

Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Harvard School of Public Health
Wake Forest University Health Sciences
Julius Center
Investigators
Principal Investigator: Kenneth Mukamal, MD Beth Israel Deaconess Medical Center
  Study Documents (Full-Text)

Documents provided by Kenneth Mukamal, Beth Israel Deaconess Medical Center:
Study Protocol  [PDF] December 4, 2017

  More Information

Publications:
Responsible Party: Kenneth Mukamal, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03169530     History of Changes
Other Study ID Numbers: MACH15
U10AA025286 ( U.S. NIH Grant/Contract )
First Submitted: May 24, 2017
First Posted: May 30, 2017
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: National Data Archive of NIMH
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: At least one year from conclusion of study.
Access Criteria: NDA approval.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kenneth Mukamal, Beth Israel Deaconess Medical Center:
cardiovascular, alcohol, diabetes

Additional relevant MeSH terms:
Cardiovascular Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs