All studies
Active not recruitingPHASE3INTERVENTIONAL

Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy

This study, for people with coronary artery disease, is comparing two key treatments. First, it investigates two different types of tiny mesh tubes called stents, named Angiolite and Xience, which are used to keep heart blood vessels open. Researchers want to see if the Angiolite stent works just as well as the Xience stent. Secondly, it compares how long people need to take anti-clotting medicines after getting a stent. Patients will either take these medicines for one month or for the standard 12 months. The main goal is to find out if the shorter medication period is safer by reducing the risk of bleeding, while still keeping the heart healthy. This will help doctors decide the best way to treat patients in the future.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
iVascular S.L.U.
Enrolment target
2,312
Start
13 Oct 2023
Estimated completion
13 Jan 2030

What is this study about?

This study is for people who have coronary artery disease, which means the blood vessels supplying their heart are narrowed. To help with this, doctors often insert a small, mesh tube called a stent to keep the vessel open. This study is looking at two types of these stents: one called Angiolite and another called Xience. The researchers want to find out if the Angiolite stent is as good as the Xience stent at keeping your heart healthy and preventing future problems.

After a stent is put in, patients usually need to take special anti-clotting medicines for a period of time to stop blood clots from forming on the stent. This study is also investigating how long people need to take these medicines. Some participants will take them for one month, while others will take them for the more usual 12 months. The study wants to see if taking the medicines for a shorter time (one month) can reduce the risk of bleeding, which is a possible side effect of these medications, without increasing other risks.

The overall aim is to improve how we treat coronary artery disease by finding the best combination of stent type and length of anti-clotting medication. This could lead to safer and more effective treatments for many people in the future.

Key takeaways

  • This study is testing different stents and anti-clotting medication durations for heart disease.
  • It compares two stent types: Angiolite and Xience.
  • It looks at taking anti-clotting medicine for 1 month versus 12 months.
  • The goal is to find safer, more effective treatments and reduce bleeding risk.
  • Participation involves a stent procedure and follow-up for 12 months.

Who may be eligible?

To be considered for this study, you need to be an adult between 18 and 95 years old. You must also have at least one narrowing in a heart blood vessel (either a natural one or a bypass graft) that doctors think can be treated with a stent. The narrowed blood vessel needs to be at least 2mm wide. Most importantly, you must be willing to understand the study and agree to take part.

There are certain reasons why you wouldn't be able to join. For example, if you're allergic to any of the medications or materials used in the stents. You can't have severe liver problems or have had a heart procedure or major bleeding in the last 30 to 45 days. If you're planning non-heart surgery soon after getting a stent, or any heart surgery, you might not be eligible. Also, if you've had a stroke recently or are already in another main clinical trial, you wouldn't be able to join. Women who could become pregnant might not be able to participate unless they've had certain procedures to prevent pregnancy.

Basically, the study is looking for people with specific heart vessel narrowings who are generally well enough to undergo the procedures and take the study medications, without other major health issues that could interfere with the results or your safety.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 95 years old?
  2. Do you have narrowed heart blood vessels suitable for a stent?
  3. Are you NOT allergic to common aspirin, anti-clotting drugs, or stent materials?
  4. Have you NOT had a stroke or major bleeding in the last 30 days?
  5. Are you NOT planning any major non-heart or heart surgery soon?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned to receive either an Angiolite or a Xience stent, and either 1 month or 12 months of anti-clotting medication (doctors will know which you receive). You'll have your stent procedure and then follow-up appointments. The main part of the study will involve monitoring your health for 12 months after your stent procedure. During this time, the study team will check for any complications, especially related to bleeding or how well the stent is working. You will have regular checks, which might include clinic visits or phone calls, to make sure you are doing well.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving advanced stent technology and close medical monitoring. However, there are also potential risks involved, which your doctor will explain in detail. These can include risks related to the stent procedure itself, side effects from the anti-clotting medicines (like bleeding), or the possibility that one treatment might not be as effective for you as another. Remember, you can choose to leave the study at any time without it affecting your usual medical care.

Locations (38)

  • IMELDA
    Verified postcode
    Bonheiden, Belgium
  • CHU Marie Curie
    Verified postcode
    Charleroi, Belgium
  • ZOL GENK
    Verified postcode
    Genk, Belgium
  • CHC Montlégia
    Verified postcode
    Liège, Belgium
  • Hospital de La Citadelle
    Verified postcode
    Liège, Belgium
  • Chu Ambroise Pare
    Verified postcode
    Mons, Belgium
  • Az Delta
    Verified postcode
    Roeselare, Belgium
  • Az Turnhout
    Verified postcode
    Turnhout, Belgium
  • Chu Lille
    Verified postcode
    Lille, France
  • Icps Massy
    Verified postcode
    Massy, France
  • Ipcs Quincy
    Verified postcode
    Quincy-sous-Sénart, France
  • Chu Toulouse
    Verified postcode
    Toulouse, France

Common questions

What is a stent?

A stent is a tiny mesh tube that doctors place in a narrowed blood vessel to help keep it open and improve blood flow to the heart.

What are anti-clotting medicines?

These are drugs that help prevent blood clots from forming. They are important after getting a stent to stop clots from blocking the new stent.

Why are there two different timeframes for medication?

Researchers want to see if taking anti-clotting medicines for a shorter time (1 month) is as safe and effective as the standard 12 months, specifically to reduce the risk of bleeding.

Will I know which stent or medication plan I get?

Yes, both you and your doctor will know which type of stent you receive and for how long you'll be taking the anti-clotting medicines. This is called 'open-label'.

What is coronary artery disease?

It's a common heart condition where the main blood vessels that supply the heart become narrowed or blocked, usually by fatty deposits.

How to find out more

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

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.