Cardiovascular DiseasesMACH15NCT03169530
Moderate Alcohol and Cardiovascular Health Trial
A study testing Alcohol in people with Cardiovascular Diseases and Diabetes, run by Beth Israel Deaconess Medical Center at 4 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cardiovascular Diseases, Diabetes
- What is being tested?
- Alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 5 Feb 2018to 15 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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;
- Abdominal aortic aneurysm (AAA) ≥5 cm with or without repair.
Who cannot join
- 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
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- 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:
- moderate - severe psychiatric illness
- behavioral concerns regarding likelihood of low adherence to trial protocol
- a medical condition likely to limit survival to less than 3 years
- 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.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Johns Hopkins ProHealth Clinical Research Center
Baltimore, Maryland, 21207
Wake Forest Sticht Center on Aging
Winston-Salem, North Carolina, 27157
About this study
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
- Being tested
- Alcohol
- Keywords
- cardiovascular, alcohol, diabetes
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholOther
Also called ethanol, beer, wine, spirits
~15 gm daily of beer, wine, or spirits for ~6 years
| Study group | Role | What they receive |
|---|---|---|
| Alcohol | Active comparator | One standard serving of alcohol (~15 gm) daily Receives: Other: Alcohol |
| Abstention | No intervention | Abstention from alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 3 months for up to 90 months or close out, or until date of death
Secondary outcomes (2)
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.
Measured: Every 3 months for up to 90 months or close out, or until date of death
Diabetes
Progression among normoglycemic and pre-diabetes individuals to American Diabetes Association (ADA)-defined diabetes.
Measured: Every 12 months for 90 months or close out, or until date of first documented occurence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start5 Feb 2018
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Why it stopped: NIH decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Balanced-design randomized trial, comparing the effects of one standard serving (\~15 grams) of alcohol intake daily to abstention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Harvard School of Public Health (HSPH), Wake Forest University Health Sciences, Julius Center
- Responsible party
- Principal investigator, Kenneth Mukamal, Beth Israel Deaconess Medical Center
- Investigators
- Kenneth J Mukamal, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169530
- Sponsor's protocol ID
- 2017P000333
- Other IDs
- U10AA025286
- Acronym
- MACH15
- Status last verified
- Feb 2019
- First submitted
- 24 May 2017
- Last updated
- 15 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sponsor prohibits data sharing.
Publications
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.
PubMed 27688006
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate Alcohol and Cardiovascular Health Trial
- ClinicalTrials.gov ID
- NCT03169530
- Acronym / sponsor ID
- MACH15 / 2017P000333
- Conditions
- Cardiovascular Diseases, Diabetes
- Keywords
- cardiovascular, alcohol, diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: NIH decision
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Harvard School of Public Health (HSPH), Wake Forest University Health Sciences, Julius Center
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Posted 30 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Balanced-design randomized trial, comparing the effects of one standard serving (~15 grams) of alcohol intake daily to abstention.
| Arm | Type | Receives |
|---|---|---|
| Alcohol | Active comparator | Other: AlcoholOne standard serving of alcohol (~15 gm) daily |
| Abstention | No intervention | –Abstention from alcohol |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (30 listed)
- High alcohol consumption, defined by any one of the following:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlcoholAlso: ethanol, beer, wine, spirits~15 gm daily of beer, wine, or spirits for ~6 years | Other | Alcohol |
Primary outcome
Cardiovascular Disease or Death
Time frame: Every 3 months for up to 90 months or close out, or until date of 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.
2 secondary outcomes
Cardiovascular Disease
Time frame: Every 3 months for up to 90 months or close out, or until date of death
Diabetes
Time frame: Every 12 months for 90 months or close out, or until date of first documented occurence
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27688006Mukamal 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.
- Individual participant dataSharing planned: No. Sponsor prohibits data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth J Mukamal, MD principal investigator
Beth Israel Deaconess Medical Center
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol in people with Cardiovascular Diseases and Diabetes, run by Beth Israel Deaconess Medical Center at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Netherlands, Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Disease or Death (time frame: Every 3 months for up to 90 months or close out, or until date of death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03169530, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.