Moderate Alcohol and Cardiovascular Health Trial

Diabetes Clinical Trial

— MACH15  

Official title:

Moderate Alcohol and Cardiovascular Health Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03169530
• Other study ID #: 2017P000333
• Secondary ID: U10AA025286
• Status: Terminated
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: June 15, 2018

Study information

• Verified date: February 2019
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 103
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes

Intervention

Other:
• Alcohol
~15 gm daily of beer, wine, or spirits for ~6 years

Locations

Country	Name	City	State
Netherlands	Julius Clinical	Zeist
Nigeria	Center for Bioethics and Research	Ibadan
United States	Johns Hopkins ProHealth Clinical Research Center	Baltimore	Maryland
United States	Wake Forest Sticht Center on Aging	Winston-Salem	North Carolina

Sponsors (5)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Harvard School of Public Health, Julius Center, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Wake Forest University Health Sciences

Countries where clinical trial is conducted

United States,  Netherlands,  Nigeria, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hard 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, or cardiovascular death.	Every 3 months for 90 month or close out, or until date of death
Other	Components of Primary Composite Endpoint	Time from baseline to the first occurrence of each of the components of primary outcome (5 outcomes).	Every 3 months for up to 90 months or close out, or until date of death
Other	Cardiovascular Death	Time from baseline to cardiovascular mortality.	Every 3 months for 90 months or closeout, or date of death
Other	Pre-Diabetes	Progression among normoglycemic individuals to ADA-defined pre-diabetes.	Every 12 months for 90 months or closeout
Primary	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	Cardiovascular Disease	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 cardiovascular mortality.	Every 3 months for up to 90 months or close out, or until date of death
Secondary	Diabetes	Progression among normoglycemic and pre-diabetes individuals to American Diabetes Association (ADA)-defined diabetes.	Every 12 months for 90 months or close out, or until date of first documented occurence