Clinical trial · Observational
Emulation of the Moderate Alcohol and Cardiovascular Health Trial (MACH15)
NCT06583161CI-TRIAL-00080379completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to assess how long-term alcohol consumption influences health risks by emulating the Moderate Alcohol and Cardiovascular Health Trial (MACH15). In the first step, the protocol of the emulation of MACH15, including eligibility criteria, alcohol regimens and assignment, follow-up, endpoints, causal contrasts of interest, and statistical analysis was specified. In the second step, the investigators will emulate an adapted version of MACH15 following the specified protocol using data from the UK Biobank.
Conditions
Conditions (15)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| All-cause Mortality | — | UNRESOLVED | — |
| Angina Pectoris | — | UNRESOLVED | — |
| Atrial Fibrillation | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cardiovascular Death | — | UNRESOLVED | — |
| Coronary Revascularization | — | UNRESOLVED | — |
| Dementia | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Heart Failure | — | UNRESOLVED | — |
| Infections | — | UNRESOLVED | — |
| Injuries | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Heavy/binge drinking | Behavioral | — | UNRESOLVED |
| Moderate drinking | Behavioral | — | UNRESOLVED |
| Quitting | Behavioral | — | UNRESOLVED |
| Social drinking | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Moderate drinkers
- description
- Participants who report drinking up to 16 grams of alcohol daily or almost daily on a repeated assessment center visit, or who report drinking 8-16 grams of alcohol 4 or more times per week on the web-based mental health questionnaire.
- interventionNames
- Behavioral: Moderate drinking
- label
- Quitters
- description
- Participants who report not drinking alcohol on a repeated assessment center visit or in the web-based mental health questionnaire.
- interventionNames
- Behavioral: Quitting
- label
- Social drinkers
- description
- Participants who report drinking up to 16 grams of alcohol 1-2 days per week or drinking 1-3 times per month or only on special occasions on a repeated assessment center visit, or who report drinking 8-16 grams of alcohol 2-3 times per week or drinking 4 times per month or less in the web-based mental health questionnaire.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion criteria: * 40-69 years old at enrollment * Currently drinking Exclusion criteria: * Within the six months prior to baseline, cardiovascular disease event (myocardial infarction, revascularization procedure, or stroke) * Hospitalization due to heart failure * History of any of the following alcohol-related conditions, confirmed by a hospital record: alcoholic cardiomyopathy, alcoholic gastritis, alcoholic liver disease, degeneration of the nervous system due to alcohol, alcoholic myopathy, alcoholic polyneuropathy, alcohol-induced acute or chronic pancreatitis, alcohol use disorder; or self-reported history of alcoholic liver disease or alcohol use disorder * Dual antiplatelet therapy or coumarin anticoagulants * Serious chronic liver disease (active hepatitis B or C infection) in the past 6 months before baseline * Personal history of any colon or liver cancer * Personal history of breast cancer * Diagnosis of dementia * Not willing or able to provide a signed and dated informed consent form * Reduced alcohol compared to 10 years ago due to illness, ill health, or doctor's advice * Self-reported poor health
References
Publications (1)
- RESULTSpiegelman D, Lovato LC, Khudyakov P, Wilkens TL, Adebamowo CA, Adebamowo SN, Appel LJ, Beulens JW, Coughlin JW, Dragsted LO, Edenberg HJ, Eriksen JN, Estruch R, Grobbee DE, Gulayin PE, Irazola V, Krystal JH, Lazo M, Murray MM, Rimm EB, Schrieks IC, Williamson JD, Mukamal KJ. The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk. Eur J Prev Cardiol. 2020 Dec;27(18):1967-1982. doi: 10.1177/2047487320912376. Epub 2020 Apr 6. PMID 32250171