Study Comparing Drug-Coated Balloon and Drug-Eluting Stents in Patients with Coronary Artery Disease at High Risk of Bleeding Using Acetylsalicylic Acid and Drug Combination

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What is this study about?

This clinical trial is focused on studying treatments for Coronary Artery Disease (CAD), a condition where the blood vessels supplying the heart become narrowed or blocked. The study will compare two different approaches for patients who are at high risk of bleeding and need a procedure called percutaneous coronary intervention (PCI). This procedure is used to open up blocked heart arteries. The trial will look at using a drug-coated balloon (DCB) compared to drug-eluting stents (DES). The goal is to see if the DCB approach, which involves a shorter period of taking two blood-thinning medications, is as effective as the DES approach, which requires a longer period of these medications.

Participants in the study will receive one of the treatments and will be monitored over time to see how well the treatment works and to check for any side effects. The medications involved in the study include Aspirin Cardio, which contains acetylsalicylic acid, Plavix, which contains clopidogrel, Efient, which contains prasugrel, and Brilique, which contains ticagrelor. These medications are commonly used to prevent blood clots in patients with heart conditions.

The study will last for several years, with participants being followed up at different intervals to assess their health and the effectiveness of the treatment. The main focus will be on the occurrence of major heart-related events and bleeding episodes. This research aims to find the best treatment strategy for patients with coronary artery disease who are at high risk of bleeding, ensuring they receive effective care with minimal side effects.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures of the trial. You will be required to provide informed written consent, confirming your understanding and willingness to participate.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes checking for conditions like stable angina or acute coronary syndromes and evaluating your risk of bleeding.

3 treatment allocation

You will be assigned to one of two treatment groups. One group will receive a drug-coated balloon (DCB) treatment, and the other will receive drug-eluting stents (DES).

4 medication regimen

You will be prescribed a dual-antiplatelet therapy (DAPT) which includes medications such as acetylsalicylic acid (Aspirin Cardio 100 mg) and either clopidogrel (Plavix 75 mg), prasugrel (Efient 10 mg), or ticagrelor (Brilique 90 mg). These medications are taken orally in the form of tablets.

The duration and dosage of the DAPT will depend on the treatment group you are assigned to. The DCB group will have a shorter DAPT duration compared to the DES group.

5 follow-up visits

Regular follow-up visits will be scheduled to monitor your health and the effectiveness of the treatment. These visits will occur at specific intervals, such as 12, 24, and 36 months after the procedure.

6 end of study

The study will conclude with a final assessment to evaluate the outcomes of the treatment. This will include checking for any major adverse cardiac events and bleeding episodes.

Who Can Join the Study?

Must be at least 18 years old.
Must provide written consent to participate.
Must have at least one major or two minor bleeding risk factors as defined by the Academic Research Consortium (ARC).
Must have either stable angina (chest pain) or dyspnea (shortness of breath) with a coronary artery narrowing that causes reduced blood flow to the heart, detected in an angiogram (a special X-ray of the heart’s blood vessels).
If stable, must have evidence of reduced blood flow to the heart, shown by either a special imaging test or a pressure measurement during coronary angiography, unless the artery is more than 90% narrowed.
If experiencing an acute coronary syndrome (ACS) such as unstable angina (UAP) or a non-ST elevation myocardial infarction (NSTEMI), must have symptoms of heart-related chest pain lasting at least 20 minutes, and specific changes in heart activity on an ECG or a rise in a heart-related blood test called high sensitivity troponin (hs-tnt).
Must have at least one new blockage in the heart’s native arteries or in a bypass graft.
The diameter of the affected blood vessel must be between 2.0 mm and 5.0 mm.
The length of the blockage must be 40 mm or less.
The blockage must be suitable for a procedure called percutaneous coronary intervention (PCI), which is a non-surgical method to open narrowed or blocked coronary arteries.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to the materials used in the study.
Patients with active bleeding or a high risk of bleeding that cannot be managed.
Patients who have had a stroke or a mini-stroke (also known as a transient ischemic attack) in the last 6 months.
Patients with severe liver disease, which means the liver is not working properly.
Patients with severe kidney disease, which means the kidneys are not working properly.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial that could interfere with this study.
Patients who have any other medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Paris – Hôpital Cochin	Paris	France
Kuopio University Hospital	Kuopio	Finland

Other Sites

Site Name	City	Country
Turku University Hospital	Turku	Finland
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis	La Rochelle	France
Pirkanmaan hyvinvointialue	Tampere	Finland
Hospital Alvaro Cunqueiro	Vigo	Spain
Central Finland Hospital District Central Finland Hospital Nova	Jyvaskyla	Finland
Hoomclkf Usfhogbedn Cytafgk Hzpddafi	Helsinki	Finland
Wdksxtcwj Swaagsjj Ciunyc Ot Nddbr Kqmzreg Slma Subq	Joensuu	Finland

Trial status

Country	Status	Recruitment Start
Finland	Recruiting	01.11.2023
France	Recruiting	01.11.2023
Spain	Recruiting	01.11.2023

Trial locations

Investigated drugs:

Drug-Coated Balloon (DCB) is a special type of balloon used in a procedure called percutaneous coronary intervention (PCI). During this procedure, the balloon is inserted into a blood vessel and inflated to open up a blocked or narrowed artery in the heart. The balloon is coated with medication that helps prevent the artery from becoming blocked again. This medication is released into the artery wall when the balloon is inflated, helping to keep the artery open over time.

Drug-Eluting Stents (DES) are small wire mesh tubes that are placed in a coronary artery during PCI to keep the artery open. These stents are coated with medication that slowly releases into the artery to prevent it from becoming blocked again. The medication helps reduce the risk of the artery narrowing over time, which can improve blood flow to the heart and reduce the risk of heart problems.

Investigated diseases:

Coronary artery disease

Coronary artery disease – Coronary artery disease is a condition where the coronary arteries, which supply blood to the heart muscle, become narrowed or blocked due to the buildup of cholesterol and other substances, known as plaque. This process is called atherosclerosis. As the arteries narrow, blood flow to the heart is reduced, which can lead to chest pain, known as angina, especially during physical activity or stress. If a plaque ruptures, it can cause a blood clot to form, potentially leading to a heart attack. Over time, the heart muscle may weaken due to reduced blood supply, affecting its ability to pump blood effectively. This disease progresses gradually and can lead to serious complications if not managed properly.

Trial ID:

2023-504340-34-01

NCT ID:

NCT04814212

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Drug-Coated Balloon and Drug-Eluting Stents in Patients with Coronary Artery Disease at High Risk of Bleeding Using Acetylsalicylic Acid and Drug Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?