Moderate Alcohol and Cardiovascular Health Trial

Not Applicable

Terminated

• Conditions: Diabetes; Cardiovascular Diseases
• Interventions: Other: Alcohol

• Registration Number: NCT03169530
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-26
• Study First Posted: 2017-05-30
• Study Start: 2018-02-05
• Primary Completion: 2018-06-15
• Study Completion: 2018-06-15
• Results First Submitted: 2018-11-30
• Results First Submitted QC: 2019-01-04
• Results First Posted: 2019-01-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-22
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 103

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alcohol	Alcohol	One standard serving of alcohol (\~15 gm) daily

Primary Outcome Measures

Name	Time	Method
Cardiovascular Disease or Death	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

Name	Time	Method
Cardiovascular Disease	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	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.

Trial Locations

Locations (4)

Julius Clinical; 🇳🇱 Zeist, Netherlands

Johns Hopkins ProHealth Clinical Research Center; 🇺🇸 Baltimore, Maryland, United States

Wake Forest Sticht Center on Aging; 🇺🇸 Winston-Salem, North Carolina, United States

Center for Bioethics and Research; 🇳🇬 Ibadan, Nigeria