RecruitingNAINTERVENTIONAL

Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI

This study is looking into better ways to treat blocked heart arteries, a condition called coronary artery disease, especially for people who are at a higher risk of bleeding. We’re comparing two common procedures: using a drug-coated balloon (DCB) and using a drug-eluting stent (DES). Both aim to open up narrowed arteries, but they work slightly differently and require different lengths of time taking anti-clotting medicines afterward. The main goal is to see if the drug-coated balloon, which allows for a shorter course of anti-clotting medication, is just as effective and safe as the standard drug-eluting stent for these patients. If it is, the study will then explore if the balloon treatment might even be better. This research is important because it could lead to safer and more comfortable treatments for people needing heart artery procedures.

At a glance

Status

Recruiting

Phase

Sponsor

North Karelia Central Hospital

Enrolment target

546

Start

01 Sep 2022

Estimated completion

01 Jan 2028

Coronary Artery Disease

What is this study about?

When arteries in your heart become blocked or narrowed, it's called coronary artery disease. This can cause chest pain or even a heart attack. A common treatment is a procedure to open these arteries, often involving a small tube called a stent that stays in place to keep the artery open. However, after getting a stent, people usually need to take anti-clotting medicines for a certain period to prevent new clots from forming. For some individuals, especially older people or those already taking blood thinners for other conditions, this anti-clotting medication can increase their risk of bleeding.

This study is comparing two ways to open blocked heart arteries. One is the standard treatment using a 'drug-eluting stent' (DES), which is a small mesh tube that releases medicine to prevent the artery from narrowing again. The other is a newer approach using a 'drug-coated balloon' (DCB). This special balloon opens the artery and leaves a small amount of medicine behind, but doesn't leave a permanent stent in the artery. An important difference is that with the drug-coated balloon, patients might be able to take anti-clotting medicines for a shorter time, which could be safer for those prone to bleeding.

The main aim of this research is to find out if the drug-coated balloon, combined with a shorter period of anti-clotting medicines, is just as effective as the standard drug-eluting stent procedure with its usual longer period of medicine. If it proves to be equally good, the study will then try to see if it might even offer advantages over the stent, particularly for patients who are at a high risk of bleeding. This could potentially reduce complications and improve outcomes for many people undergoing these important heart procedures.

Key takeaways

This study compares two heart artery treatments: a drug-coated balloon and a drug-eluting stent.
It's for people with blocked heart arteries who are at a high risk of bleeding.
The goal is to see if the balloon, with less anti-clotting medicine, is as good as the stent.
Participation could mean better understanding and safer options for heart patients.
You will receive close medical monitoring if you join.
You can always choose to leave the study at any point.

Who may be eligible?

This study is looking for adults aged 18 or older who have coronary artery disease (blocked heart arteries) and are at a higher risk of bleeding. Your doctor will assess your bleeding risk based on several factors.

You might be considered at high bleeding risk if you currently take blood thinners, have certain kidney or liver conditions, have a history of significant bleeding, or have very low levels of platelets (cells that help blood clot). Other factors like being over 75, having milder kidney issues, or taking certain long-term medications can also contribute.

To be part of the study, you also need to have symptoms like chest pain or breathlessness that suggest a blockage in your heart arteries, which your doctor will confirm through tests. This could be a stable problem or a more urgent situation like unstable angina or a specific type of heart attack.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with blocked heart arteries?
Do you take long-term blood thinners, or have you been told you're at high risk of bleeding?
Have you had recent heart symptoms like chest pain or breathlessness due to artery blockage?
Are you willing to participate in follow-up visits and assessments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

The length of your participation in this study will depend on the treatment you receive and requires follow-up visits and assessments. You will undergo either a procedure with a drug-coated balloon or a drug-eluting stent to open your blocked heart artery. After the procedure, you will be prescribed anti-clotting medications for a specific duration, which will be determined by which treatment you receive. You will have regular check-ups and tests, which may include blood tests and heart scans, to monitor your recovery and the effectiveness of the treatment. The total duration of follow-up for this study can last for an extended period to fully understand the long-term effects of the treatments.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as receiving close medical monitoring and access to advanced treatments for your heart condition, which might lead to better outcomes, especially if the drug-coated balloon proves beneficial for high-bleeding-risk patients. However, like all medical procedures and medications, there are potential risks involved. These could include risks related to the heart procedure itself (like bleeding or infection), side effects from the medications, or the possibility that the new treatment might not be as effective as the standard one. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

Central Hospital of Central Finland
Jyväskylä, Finland· Not yet recruiting
Central Hospital of Lapland
Rovaniemi, Finland· Not yet recruiting
Kuopio University Hospital
Kuopio, Finland· Not yet recruiting
Turku University Hospital
Turku, Finland· Not yet recruiting
Helsinki University Hospital
Helsinki, Finland· Not yet recruiting
North Karelia Central Hospital
Joensuu, Finland· Recruiting
Central Hospital of Päijät-Häme
Lahti, Finland· Recruiting
Oulu university hospital
Oulu, Finland· Not yet recruiting
Satakunta Central Hospital
Pori, Finland· Not yet recruiting
Tampere Heart Hospital
Tampere, Finland· Not yet recruiting
Centre Hospitalier La Rochelle
La Rochelle, France· Not yet recruiting
University Hospital of Carl Gustav Carus
Dresden, Germany· Not yet recruiting

+2 more sites — see the official record for the full list.

Common questions

What is coronary artery disease?

It's a condition where the arteries that supply blood to your heart become narrowed or blocked, often due to a build-up of fatty deposits. This can reduce blood flow to your heart.

Why is bleeding risk important in this study?

After heart artery procedures, people often need anti-clotting medicines. For those already at high risk of bleeding, these medicines can increase the chance of serious bleeding complications, so finding safer options is key.

What is the difference between a 'drug-coated balloon' and a 'drug-eluting stent'?

A drug-coated balloon opens the artery and leaves medicine behind, but no permanent device. A drug-eluting stent is a small mesh tube that stays in place permanently and also releases medicine.

Will I know which treatment I receive?

In some studies, participants might not know which treatment they are receiving to ensure fair comparison. However, the study team will explain how this works when you discuss participation.

What does 'shorter DAPT regimen' mean?

DAPT stands for 'dual antiplatelet therapy,' which are anti-clotting medicines. A 'shorter regimen' means you might need to take these medicines for a reduced period compared to the standard treatment.

How to find out more

Tuomas Rissanen, MD, PhD

tuomas.rissanen@siunsote.fi +358505998022 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.