Moderate Alcohol and Cardiovascular Health Trial

NCT03169530 | Terminated Results DMC

• 2 other identifiers: 2017P000333U10AA025286
• Study Type: interventional
• Target: 103
• Locations: 3 countries
• Sites: 4

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.

Conditions

Cardiovascular Diseases; Diabetes

Keywords

cardiovascular, alcohol, diabetes

Outcome Measures

Primary Outcomes (1)

• Cardiovascular Disease or 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.

  Every 3 months for up to 90 months or close out, or until date of death

Secondary Outcomes (2)

• Cardiovascular Disease

  Every 3 months for up to 90 months or close out, or until date of death

• Diabetes

  Every 12 months for 90 months or close out, or until date of first documented occurence

Other Outcomes (4)

• Hard Cardiovascular Disease or Death

  Every 3 months for 90 month or close out, or until date of death

• Components of Primary Composite Endpoint

  Every 3 months for up to 90 months or close out, or until date of death

• Cardiovascular Death

  Every 3 months for 90 months or closeout, or date of death

Study Arms (2)

Alcohol

ACTIVE COMPARATOR

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

Other: Alcohol

Abstention

NO INTERVENTION

Abstention from alcohol

Interventions

Alcohol OTHER

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

Also known as: ethanol, beer, wine, spirits

Alcohol

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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 \[CVD\])
• Clinical CVD (more than 6 months prior to randomization), defined by:
• Previous myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), carotid endarterectomy (CE), carotid stenting;
• Peripheral artery disease (PAD) with revascularization;
• Acute coronary syndrome with or without resting electrocardiogram (ECG) change, ECG changes on a graded exercise test (GXT), or positive cardiac imaging study;
• Prior stroke documented on brain imaging or with a persistent deficit.
• Subclinical CVD, confirmed in available medical records:
• At least a 50% diameter stenosis of a coronary, carotid, or lower extremity artery;
• Coronary artery calcium score ≥400 Agatston units;
• Ankle brachial index (ABI) ≤0.90;
• Left ventricular hypertrophy (LVH) by ECG (based on computer reading), echocardiogram report, or other cardiac imaging procedure report;

You may not qualify if:

• High alcohol consumption, defined by any one of the following:
• Alcohol Use Disorders Identification Test (AUDIT) score \>5 at screening
• Drinking, on average, \>7 alcoholic beverages/week during the past 6 months
• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Harvard School of Public Health (HSPH): collaborator
• Wake Forest University Health Sciences: collaborator
• Julius Center: collaborator

Study Sites (4)

Johns Hopkins ProHealth Clinical Research Center

Baltimore, Maryland, 21207, United States

Location

Wake Forest Sticht Center on Aging

Winston-Salem, North Carolina, 27157, United States

Location

Julius Clinical

Zeist, Netherlands

Location

Center for Bioethics and Research

Ibadan, 200001, Nigeria

Location

Related Publications (1)

• Mukamal KJ, Clowry CM, Murray MM, Hendriks HF, Rimm EB, Sink KM, Adebamowo CA, Dragsted LO, Lapinski PS, Lazo M, Krystal JH. Moderate Alcohol Consumption and Chronic Disease: The Case for a Long-Term Trial. Alcohol Clin Exp Res. 2016 Nov;40(11):2283-2291. doi: 10.1111/acer.13231. Epub 2016 Sep 30.

  PMID: 27688006 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus

Interventions

Ethanol; Beer; Wine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Alcoholic Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Beverages; Fermented Foods; Food and Beverages

Results Point of Contact

• Title: Kenneth Mukamal, MD, MPH
• Organization: Beth Israel Deaconess Medical Center

kmukamal@bidmc.harvard.edu

617 754-1401

Study Officials

• Kenneth J Mukamal, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical outcome events will be assessed through medical record review by a masked Medical Safety Officer (MSO).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: February 5, 2018
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: March 15, 2019
• Results First Posted: January 30, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); US (2); NG (1)