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Study Comparing Dabigatran with Ticagrelor or Clopidogrel for Patients with Acute Coronary Syndrome Undergoing PCI

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What is this study about?

This clinical trial is focused on studying treatments for patients with Acute Coronary Syndrome (ACS), a condition where the blood supply to the heart is suddenly blocked. The study involves comparing two different dual therapies. One therapy combines the medication Dabigatran with Ticagrelor (also known by its code name AZD6140), and the other combines Dabigatran with Clopidogrel. These medications are used to prevent blood clots in patients who have undergone a procedure called Percutaneous Coronary Intervention (PCI), which is a non-surgical method to open narrowed or blocked blood vessels of the heart.

The purpose of the study is to observe and compare the effects of these two treatment combinations in real-world settings. Participants will be randomly assigned to receive one of the two therapies. The study will last for about 12 months, during which the main focus will be on monitoring any bleeding events that occur. Additionally, the study will look at other important outcomes such as heart attacks, strokes, and any instances of blood clots forming in the stents used during PCI.

Throughout the study, participants will be closely monitored to ensure their safety and to gather data on the effectiveness of the treatments. The goal is to better understand which combination of medications provides the best balance between preventing blood clots and minimizing the risk of bleeding in patients with ACS who have undergone PCI.

1 joining the study

Participation begins after meeting specific criteria, including age 18 or older, successful stenting with a drug-eluting stent, and an indication for oral anticoagulation.

Written informed consent is required before proceeding.

2 medication administration

The study involves dual therapy with dabigatran and either ticagrelor or clopidogrel.

Ticagrelor is administered orally. The specific dosage and frequency are determined by the healthcare provider based on individual needs.

3 follow-up period

The primary focus during the follow-up is monitoring for any bleeding events, which are assessed using a specific scoring system.

The follow-up period lasts for 12 months, during which any major or clinically relevant non-major bleeding events are recorded.

4 evaluation of secondary outcomes

Secondary outcomes include the occurrence of thromboembolic events such as heart attack, stroke, or systemic embolism, as well as death.

These events are monitored throughout the study to assess the effectiveness of the treatment.

5 completion of the study

The study is estimated to conclude by May 7, 2025.

Final assessments are conducted to evaluate the overall outcomes and effectiveness of the treatment strategies.

Who Can Join the Study?

  • Must be 18 years or older.
  • Must have undergone PCI (a procedure to open blocked heart arteries) and had a Drug Eluting Stent (DES) successfully placed.
  • Must have a need for a NOAC (a type of blood thinner) or be starting on oral anticoagulation. This includes patients with atrial fibrillation (a type of irregular heartbeat).
  • Must provide written informed consent to participate in the study.
  • Must meet one of the following conditions:
    • Admitted to the hospital with ACS (a group of heart conditions including unstable angina, NSTEMI, or STEMI).
    • Undergoing a high risk PCI, which includes:
      • Chronic Total Occlusion (a completely blocked artery).
      • Two-stent bifurcation lesion (a complex stenting procedure).
      • Total stent length of more than 60mm in the initial procedure.
      • Venous graft stenting (stenting in a vein used for bypass surgery).
    • Having type I or II diabetes mellitus that is being treated with medication.

Who Cannot Join the Study?

  • Patients who have a history of severe allergic reactions to the study medications.
  • Patients with active bleeding or a high risk of bleeding.
  • Patients with severe liver disease, which means the liver is not working well.
  • Patients with kidney problems that are severe enough to affect medication processing.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of stroke or a mini-stroke, which is a temporary blockage of blood flow to the brain.
  • Patients with a condition called thrombocytopenia, which means having a low number of platelets in the blood.
  • Patients with a condition called anemia, which means having a low number of red blood cells.
  • Patients with a history of peptic ulcer disease, which is a sore in the lining of the stomach or the first part of the small intestine.
  • Patients with a history of intracranial hemorrhage, which is bleeding inside the skull.
  • Patients who have had recent major surgery or injury.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of alcohol or drug abuse.
  • Patients who are unable to follow the study procedures or take the study medications as directed.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
16.03.2021

Trial locations

Investigated drugs:

Dabigatran is a medication used to prevent blood clots in patients who have certain heart conditions. It works by making the blood less likely to form clots, which can help prevent strokes and other serious problems.

Ticagrelor is a medication that helps prevent blood clots by stopping platelets in the blood from sticking together. It is often used in patients who have had a heart attack or other heart-related issues to reduce the risk of further heart problems.

Clopidogrel is another medication that prevents blood clots by keeping platelets from clumping together. It is commonly used in patients who have had a heart attack, stroke, or other conditions that increase the risk of blood clots.

Investigated diseases:

Acute Coronary Syndrome – Acute coronary syndrome is a term used to describe a range of conditions associated with sudden, reduced blood flow to the heart. It often results from the buildup of fatty deposits in and on the walls of coronary arteries, which can rupture and form a clot. This condition can lead to chest pain or discomfort, often described as a feeling of pressure or tightness in the chest. The pain may also radiate to the shoulders, arms, neck, jaw, or back. It can occur suddenly and may be accompanied by shortness of breath, sweating, or nausea. The progression of acute coronary syndrome can lead to more severe heart conditions if not addressed promptly.

Trial ID:
2024-518666-27-00
NCT ID:
NCT04688723
Trial Phase:
Human Pharmacology (Phase I) – Other

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