Study on MK-0616 for Reducing Heart Disease Events in Patients with Atherosclerotic Cardiovascular Disease

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What is this study about?

This clinical trial is focused on studying a condition known as Atherosclerotic Cardiovascular Disease (ASCVD). This disease involves the buildup of fatty deposits in the arteries, which can lead to serious heart problems. The study is testing a new treatment called MK-0616, which is a film-coated tablet developed by Merck & Co. Inc. The purpose of the study is to evaluate how effective and safe MK-0616 is in reducing major heart-related events in people who are at high risk for cardiovascular issues.

Participants in the study will be randomly assigned to receive either the MK-0616 tablet or a placebo, which looks like the real medication but does not contain the active ingredient. The study will monitor participants over a period to see if MK-0616 can help delay or prevent serious events such as heart attacks, strokes, or other cardiovascular complications. The study aims to understand if MK-0616 can increase the time before a participant experiences a major heart-related event.

Throughout the study, participants will continue their usual care and medications, and their health will be closely monitored by the research team. The study will also look at changes in cholesterol levels and other markers that are important for heart health. The goal is to gather information that could lead to better treatments for people with high cardiovascular risk due to ASCVD.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes a review of medical history and current medications.

Eligibility criteria include a history of major atherosclerotic cardiovascular disease (ASCVD) events or being at high risk for a first major ASCVD event.

2 screening visit

A screening visit is conducted to evaluate fasting lipid values. This involves a blood test to measure LDL-C and non-HDL-C levels.

Participants must be on a stable dose of statins or other lipid-lowering therapies for at least 30 days before this visit.

3 randomization

Participants are randomly assigned to receive either the MK-0616 tablet or a placebo. This is a film-coated tablet taken orally.

The purpose is to compare the effects of MK-0616 with a placebo in reducing major adverse cardiovascular events.

4 treatment phase

During the treatment phase, participants take the assigned tablet daily. The dosage and frequency are determined by the study protocol.

Regular follow-up visits are scheduled to monitor health and any side effects.

5 follow-up assessments

Follow-up assessments include monitoring for any cardiovascular events such as heart attacks or strokes.

Blood tests are conducted periodically to measure changes in cholesterol levels and other relevant biomarkers.

6 completion of study

The study is estimated to conclude by November 2029.

Final assessments are conducted to evaluate the overall efficacy and safety of MK-0616.

Who Can Join the Study?

You must be at least 18 years old.
You should have a history of a major event related to ASCVD (Atherosclerotic Cardiovascular Disease), such as:
- At least 30 days after a heart attack (caused by plaque rupture or erosion).
- At least 30 days after an ischemic stroke (caused by atherosclerosis).
- At least 30 days after successful surgery or procedure to open blocked arteries in the neck or legs, or major amputation due to atherosclerosis.
If you are at high risk for a first major ASCVD event, you should meet one of the following:
- Be at least 50 years old with signs of coronary artery disease (problems with the heart’s blood vessels).
- Be at least 50 years old with signs of atherosclerotic cerebrovascular disease (problems with blood vessels in the brain).
- Be at least 50 years old with signs of peripheral artery disease (problems with blood vessels in the legs).
- Be at least 60 years old with diabetes and at least one of the following:
  - Microvascular disease (small blood vessel problems).
  - Urine albumin-creatinine ratio of at least 30 mg/mmol within 6 months before the first visit.
  - Daily insulin use.
  - Having diabetes for at least 10 years.
Your fasting lipid values (cholesterol levels) at the first visit should be:
- If you have a history of a major ASCVD event: LDL-C (bad cholesterol) of at least 70 mg/dL or non-HDL-C of at least 100 mg/dL.
- If you are at high risk for a first major ASCVD event: LDL-C of at least 90 mg/dL or non-HDL-C of at least 120 mg/dL.
You should be taking a moderate- or high-intensity statin (a type of cholesterol-lowering medication) with or without other lipid-lowering treatments at the first visit.
You should be on a stable dose of all cholesterol-lowering treatments (including statins and other medications) for at least 30 days before the first visit, with no plans to change the medication or dose during the study.

Who Cannot Join the Study?

Patients who have a different heart condition that is not related to ASCVD (Atherosclerotic Cardiovascular Disease) cannot participate.
Individuals who are not within the specified age range for the study are excluded.
Participants who are not part of the specified clinical trial groups are not eligible.
People who are considered part of a vulnerable population, which means they might need special protection or care, are not allowed to join the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Sydvestjysk Sygehus	Esbjerg	Denmark

Other Sites

Site Name	City	Country
Sanos A/S	Gandrup	Denmark
Slagelse Hospital	Slagelse	Denmark
Region Midtjylland	Aarhus	Denmark
Odense University Hospital	Odense	Denmark
Gentofte Hospital	Hellerup	Denmark
Regionshospital Nordjylland	Hjørring	Denmark
Zealand University Hospital	Koege	Denmark
Ralmwp Mnfoxomdunu	Herning	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	08.11.2023

Trial locations

Investigated drugs:

Mk-0616

MK-0616 is a medication being studied to see if it can help reduce the risk of major cardiovascular events, such as heart attacks or strokes, in people who are at high risk for heart disease. The trial is focused on determining whether this medication can effectively delay the occurrence of these serious heart-related events.

Atherosclerotic Cardiovascular Disease – Atherosclerotic Cardiovascular Disease (ASCVD) is a condition characterized by the buildup of fatty deposits, known as plaques, within the walls of arteries. This buildup leads to the narrowing and hardening of the arteries, which can restrict blood flow. Over time, the reduced blood flow can result in various cardiovascular complications, such as heart attacks or strokes. The disease progresses as plaques continue to accumulate, potentially leading to blockages or ruptures. These events can cause significant damage to the heart or brain, depending on the location of the affected arteries. The progression of ASCVD is influenced by factors such as diet, lifestyle, and genetic predisposition.

Trial ID:

2022-502781-24-00

Protocol code:

MK 0616-015

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on MK-0616 for Reducing Heart Disease Events in Patients with Atherosclerotic Cardiovascular Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?