MACH15Moderate Alcohol and Cardiovascular Health Trial

Date de début de l'étude : 5 février 2018

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.