Moderate Alcohol and Cardiovascular Health Trial

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2018-06-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiovascular Diseases Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Balanced-design randomized trial, comparing the effects of one standard serving (\~15 grams) of alcohol intake daily to abstention.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Clinical outcome events will be assessed through medical record review by a masked Medical Safety Officer (MSO).

Study Groups

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Alcohol

One standard serving of alcohol (\~15 gm) daily

Group Type ACTIVE_COMPARATOR

Alcohol

Intervention Type OTHER

\~15 gm daily of beer, wine, or spirits for \~6 years

Abstention

Abstention from alcohol

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Alcohol

\~15 gm daily of beer, wine, or spirits for \~6 years

Intervention Type OTHER

Other Intervention Names

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ethanol, beer, wine, spirits

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No