Study of acetylsalicylic acid and clopidogrel treatment duration after left atrial appendage closure in patients with atrial fibrillation

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What is this study about?

This study focuses on patients with atrial fibrillation who have undergone a procedure called left atrial appendage closure, which helps prevent blood clots in the heart. The study examines two blood-thinning medications: acetylsalicylic acid (commonly known as aspirin) and clopidogrel, which are used to prevent blood clots after the procedure.

The purpose of this research is to determine the safest and most effective way to use these blood-thinning medications after the closure procedure. The study compares different durations of treatment: some patients will take both medications for 30 days and then continue with just one medication for 6 months, while others will take both medications for the full 6 months.

The medications are taken by mouth once daily, with each tablet containing 75 mg of either acetylsalicylic acid or clopidogrel. The study will monitor patients for any heart-related events and bleeding complications to determine which treatment approach provides the best balance of preventing blood clots while minimizing bleeding risks.

1 Initial medication phase

After successful left atrial appendage closure (a procedure to prevent blood clots in the heart), you will receive two medications:

– Acetylsalicylic acid (aspirin) taken by mouth

– Clopidogrel taken by mouth

Both medications need to be taken daily for the first 30 days after the procedure

2 Medication adjustment period

After the first 30 days, you will be assigned to one of two groups:

Group 1: Continue taking only one blood-thinning medication (either aspirin or clopidogrel) until 6 months after the procedure

Group 2: Continue taking both medications (aspirin and clopidogrel) for 6 months after the procedure

3 Long-term treatment phase

After 6 months, you will either:

– Continue taking one blood-thinning medication, or

– Stop all blood-thinning medications

This phase will continue until the end of the study period

4 Monitoring period

Throughout the study, you will be monitored for:

– Any signs of stroke or mini-stroke

– Heart-related events

– Any bleeding events

The total duration of the study continues until December 31, 2027

Who Can Join the Study?

Had successful left atrial appendage closure (a heart procedure to prevent blood clots) with either Amplatzer or WATCHMAN devices within the past 37 days
Currently taking dual antiplatelet therapy (two blood-thinning medications – aspirin and clopidogrel) since the procedure
Age 18 years or older
Willing to follow all study requirements, including:
- Taking medications as assigned by the study
- Attending all follow-up visits
Able and willing to provide written informed consent

Who Cannot Join the Study?

Age below 18 years or above 90 years
Unable to provide informed consent
Active bleeding or high risk of bleeding that prevents use of blood-thinning medications
Known allergies to antiplatelet medications (medications that prevent blood clots)
Severe kidney disease requiring dialysis
Life expectancy less than 12 months
Pregnancy or breastfeeding
Recent major surgery within the last 30 days
History of blood clotting disorders
Participation in another clinical trial within the past 30 days
Active infection or inflammation that could affect the procedure
Significant heart valve disease
Previous stroke within the last 30 days
Uncontrolled high blood pressure (blood pressure that remains high despite treatment)
Active cancer requiring treatment

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country	Status
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland

Other Sites

Site Name	City	Country
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy	Warsaw	Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Slaskie Centrum Chorob Serca W Zabrzu	Zabrze	Poland
Gornoslaskie Centrum Mwdyczne	Katowice	Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Uaxdcasmlyajmr Chektry Kbinmuprj	Gdansk	Poland
Sqbfiatq Piszdaeqs Seb z omfr	Gdynia	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not yet recruiting	23.01.2018

Trial locations

Investigated drugs:

Based on the trial information provided, the medications involved are:

Aspirin – A common antiplatelet medication that helps prevent blood clots by making platelets less sticky. It’s used to reduce the risk of stroke and other cardiovascular events.

Clopidogrel – An antiplatelet medication that works differently from aspirin to prevent blood clots. When used together with aspirin, it’s called dual antiplatelet therapy (DAPT).

The trial compares different durations of antiplatelet therapy after a Left Atrial Appendage Closure (LAAC) procedure, using either single antiplatelet therapy (SAPT) with one medication or dual antiplatelet therapy (DAPT) with both medications together.

Investigated diseases:

Atrial fibrillation

Atrial fibrillation – A heart rhythm disorder where the upper chambers of the heart beat irregularly and out of sync with the lower chambers. This condition occurs when the heart’s electrical signals become chaotic, causing an irregular and often rapid heartbeat. The irregular rhythm can cause blood to pool in the heart chambers, which affects the heart’s ability to pump blood efficiently. The condition can be persistent or come and go in episodes. Atrial fibrillation often causes symptoms like heart palpitations, shortness of breath, and fatigue. People may experience different levels of symptoms, from barely noticeable to very pronounced.

Trial ID:

2024-516382-37-00

Protocol code:

2.52/IV/16

NCT ID:

NCT03445949

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of acetylsalicylic acid and clopidogrel treatment duration after left atrial appendage closure in patients with atrial fibrillation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?