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Moderate Alcohol and Cardiovascular Health Trial

NCT03169530 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2019-03-15

Study results available
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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

Interventions

OTHER

Alcohol

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

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • Wake Forest University Health Sciences

    collaborator OTHER

  • Julius Center

    collaborator OTHER

  • Beth Israel Deaconess Medical Center

    lead OTHER

Principal Investigators

  • Kenneth J Mukamal, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-05
Primary Completion
2018-06-15
Completion
2018-06-15

Countries

  • United States
  • Netherlands
  • Nigeria

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03169530 on ClinicalTrials.gov