Study on Dabigatran and Ticagrelor for Patients with Acute Coronary Syndrome and Atrial Fibrillation Undergoing Heart Procedure

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What is this study about?

This clinical trial is focused on patients with Acute Coronary Syndrome and Non-valvular Atrial Fibrillation who are undergoing a procedure called Percutaneous Coronary Intervention. The study is examining the effects of two different treatment approaches. One group will receive a combination of medications known as dual antithrombotic therapy, which includes a reduced dose of Ticagrelor (also known by its code name AZD6140) and a standard dose of Dabigatran. The other group will receive a triple therapy that includes Clopidogrel, Aspirin, and Dabigatran. The purpose of the study is to compare the safety and effectiveness of these two treatment methods, particularly looking at the risk of bleeding and protection against heart-related issues.

Participants in the study will be randomly assigned to one of the two treatment groups. The study will monitor the occurrence of any major or significant bleeding events, as well as other heart-related events such as heart attacks, strokes, or the need for additional heart procedures. The study aims to determine if the dual therapy is as safe and effective as the triple therapy in managing these conditions.

The trial will take place over a period of time, with participants receiving their assigned treatment and being regularly monitored by healthcare professionals. The study will help to provide valuable information on the best treatment options for patients with these heart conditions, potentially improving care and outcomes for future patients.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria. These include being between 18 and 99 years old, having non-valvular atrial fibrillation (AF), and having undergone a successful percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS).

2 randomization

Participants are randomly assigned to one of two treatment groups. The study group receives dual antithrombotic therapy with a reduced dose of ticagrelor and standard-of-care dabigatran. The control group receives triple therapy with clopidogrel, aspirin, and dabigatran.

3 medication administration

For the study group, ticagrelor is administered orally in the form of film-coated tablets. The dosage is either 90 mg or 60 mg, depending on the specific requirements of the study protocol.

The control group receives clopidogrel and aspirin in addition to dabigatran. The exact dosages and frequency are determined by the study protocol and standard medical guidelines.

4 monitoring and follow-up

Participants are monitored for any major or clinically relevant non-major bleeding events. This is a primary endpoint of the study.

Secondary endpoints include monitoring for thromboembolic events such as myocardial infarction (MI), stroke, systemic embolism, death, or unplanned revascularization procedures like PCI or coronary artery bypass grafting (CABG).

5 study duration

The study is expected to continue until June 30, 2026. Participants will be involved in the study for the duration specified in the study protocol, which includes regular follow-ups and assessments.

Who Can Join the Study?

Male and female patients aged 18-99 years can participate.
Patients must have a condition called non-valvular atrial fibrillation (AF), which is a type of irregular heartbeat not caused by a heart valve problem. They should have been taking a medication called dabigatran for at least two doses before joining the study, or they should not have been treated before a procedure called percutaneous coronary intervention (PCI). AF can be occasional, ongoing, or permanent, but it should not be due to a temporary issue like a heart attack, blood clot in the lungs, recent surgery, inflammation of the heart lining, or an overactive thyroid unless long-term treatment with a blood thinner is expected.
Patients should have experienced a heart problem called acute coronary syndrome (ACS) and have had a successful PCI, which is a procedure to open blocked heart arteries, within the last 120 hours. ACS can include a heart attack with or without certain changes on an ECG or a condition called unstable angina, which is chest pain due to reduced blood flow to the heart.
Patients must be able to understand and agree to participate in the study by giving their consent, following international and local guidelines and rules.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to any of the study medications.
Individuals with active bleeding or a high risk of bleeding, which means they are more likely to bleed easily.
Patients with severe liver disease, as this can affect how the body processes medications.
Individuals with a history of stroke or any other serious brain injury.
Patients who are pregnant or breastfeeding, as the study medications may affect the baby.
Individuals with severe kidney problems, which can impact how the body handles the medications.
Patients who are currently participating in another clinical trial, as this could interfere with the study results.
Individuals who have had a heart attack or heart surgery within the last 30 days.
Patients with uncontrolled high blood pressure, meaning their blood pressure is not well-managed with treatment.
Individuals with 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

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Other Sites

Site Name	City	Country
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy	Bydgoszcz	Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Gornoslaskie Centrum Mwdyczne	Katowice	Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Uniwersytecki Szpital Kliniczny W Opolu	Opole	Poland
American Heart Of Poland S.A.	Kedzierzyn-Kozle	Poland
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy	Warsaw	Poland
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego	Lodz	Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu	Torun	Poland
Wojewodzki Szpital Specjalistyczny We Wroclawiu	Wroclaw	Poland
Wojewodzki Szpital Specjalistyczny W Olsztynie	Olsztyn	Poland
Wojewodzki Szpital Zespolony W Elblagu SPZOZ	Elblag	Poland
Kyjlmui Kjrynlmtits Ktzqd w Bnxdqht Bdixuow Cyuumya Khnloftqnil i Kixyvznjouqkitc Pits	Bielsko-Biala	Poland
Slncnic śmu Wdpgtxffbe Csrzoeuczi Pb	Gdansk	Poland
Uhoujgwzftmsov Cuoxhqu Krjyfbuke	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	01.03.2021

Trial locations

Investigated drugs:

Ticagrelor

Dabigatran is a medication used to prevent blood clots in patients with certain heart conditions. In this trial, it is part of both the study and control groups to help reduce the risk of stroke and other complications by thinning the blood.

Ticagrelor is an antiplatelet medication that helps prevent blood clots by stopping platelets from sticking together. In this study, it is used in a reduced dose as part of the dual antithrombotic therapy to evaluate its safety and effectiveness in combination with dabigatran.

Clopidogrel is another antiplatelet drug that prevents blood clots by inhibiting platelets. It is used in the control group as part of the triple therapy to compare its effects with the dual therapy involving ticagrelor.

Aspirin is a common medication that reduces pain, fever, and inflammation. It also has antiplatelet properties, which help prevent blood clots. In this trial, aspirin is included in the control group as part of the triple therapy to assess its role in preventing clot-related complications.

Investigated diseases:

Acute coronary syndrome

Acute Coronary Syndrome – This 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, which may spread to the arms, neck, jaw, or back. It can also cause shortness of breath, sweating, or nausea. The progression can vary, potentially leading to a heart attack if not managed.

Non-valvular Atrial Fibrillation – This is a type of irregular heartbeat that is not caused by a heart valve issue. It occurs when the heart’s upper chambers beat out of sync with the lower chambers, leading to poor blood flow. Symptoms may include heart palpitations, shortness of breath, and fatigue. The condition can lead to blood clots forming in the heart, which may travel to other parts of the body. Over time, it can increase the risk of stroke and other heart-related complications.

Percutaneous Coronary Intervention – This is a non-surgical procedure used to treat narrowing of the coronary arteries of the heart. It involves the insertion of a catheter with a balloon at its tip, which is inflated to open up the artery. Often, a stent is placed to keep the artery open. The procedure helps improve blood flow to the heart muscle, relieving symptoms such as chest pain. It is commonly used in patients with acute coronary syndrome to restore blood flow.

Trial ID:

2024-515056-20-00

Protocol code:

NBK182/1/2020

NCT ID:

NCT04695106

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Dabigatran and Ticagrelor for Patients with Acute Coronary Syndrome and Atrial Fibrillation Undergoing Heart Procedure

What is this study about?

Who Can Join the Study?

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