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Atrial fibrillation – Trials in Disease

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Clinical Trials for Atrial Fibrillation: Ongoing Studies and Treatment Options

Atrial fibrillation is a common heart rhythm disorder that affects millions of people worldwide. Currently, there are 40 ongoing clinical trials testing various medications and treatment approaches to prevent complications such as stroke, bleeding, and irregular heartbeats. These trials are taking place across multiple countries in Europe, investigating medications including blood thinners, heart rhythm drugs, and other treatments designed to improve outcomes for patients with this condition.

Clinical trial locations

Study Comparing Single and Dual Antiplatelet Therapy with Clopidogrel and Acetylsalicylic Acid for Patients with Atrial Fibrillation Undergoing Left Atrial Appendage Closure

This Italian study focuses on patients who have undergone a procedure called left atrial appendage closure using the Amulet device. After this heart procedure, patients need medication to prevent blood clots. The trial compares two approaches: taking one medication versus taking two medications together.

Who can participate: Adults 18 years or older who have had successful left atrial appendage closure and have irregular heartbeats. Patients must have a high risk of stroke based on medical scoring systems and cannot take long-term blood thinning medications due to high bleeding risk.

Who cannot participate: Patients not undergoing the specific procedure with the Amulet device, those outside the age range, vulnerable populations, and those who don’t meet other study criteria.

What the study tests: The trial examines whether taking just clopidogrel (Plavix) alone is as effective as taking both clopidogrel and acetylsalicylic acid (aspirin) together. These medications help prevent blood clots by stopping platelets from sticking together. Patients will take these medications for 6 months after their procedure.

Main goals: The study aims to see if single medication therapy can prevent blood clots, stroke, and death just as well as taking two medications together, while potentially reducing bleeding risks.

Study of Allopurinol to Reduce Cardiovascular Events in High-Risk Patients with Heart Disease and Long-COVID Syndrome

This Polish study examines whether allopurinol, a medication that lowers uric acid levels, can help reduce heart problems in people with high cardiovascular risk, including those with long-COVID symptoms.

Who can participate: Adults between 40 and 70 years old with elevated blood uric acid levels who have at least one high-risk heart condition such as previous stroke, heart failure, poor blood flow to legs, irregular heartbeat, diabetes, or high blood pressure with organ damage.

Who cannot participate: People currently taking uric acid-lowering medications, those with severe kidney or liver disease, active cancer, pregnant or breastfeeding women, and those with recent major surgery or unstable medical conditions.

What the study tests: Half the participants will receive allopurinol tablets while the other half receives usual care. The treatment continues for approximately 5 years with regular monitoring including heart examinations, blood vessel checks, and blood tests.

Main goals: To determine if allopurinol can prevent serious cardiovascular events like heart attacks and strokes while monitoring its effects on heart function, blood vessel health, and long-COVID symptoms.

Study of AP31969 compared to placebo to control heart rhythm in patients with atrial fibrillation

This multi-country trial (Hungary, Bulgaria, Netherlands, Poland, Italy, Denmark, Germany) investigates AP31969, an experimental medication for controlling irregular heart rhythm in people with atrial fibrillation.

Who can participate: Adults 18 years or older with confirmed irregular heartbeats occurring between 1% and 90% of the time. Participants must be willing to have a small loop recorder device implanted under their skin to monitor heart rhythm and must use reliable birth control methods during the study.

Who cannot participate: People aged below 18 or above 65 years, those with severe heart valve problems, uncontrolled high blood pressure, severe kidney or liver disease, active bleeding disorders, recent heart surgery (within 6 months), or history of stroke.

What the study tests: The medication AP31969 is tested against a placebo to see if it can reduce how often and how long irregular heart rhythms occur. Participants take tablets orally for 12 weeks while their heart rhythm is continuously monitored through an implanted device.

Main goals: To evaluate whether AP31969 effectively reduces irregular heartbeat episodes and improves quality of life, while carefully monitoring for any bleeding events or other complications.

Study on Amiodarone for Patients with Persistent Atrial Fibrillation Undergoing Electrical Cardioversion

This Spanish study compares two different time frames for taking amiodarone before a procedure that helps restore normal heart rhythm.

Who can participate: Adults 18 years or older with irregular heartbeats lasting 7 days or more who are scheduled for electrical cardioversion while taking amiodarone. Participants must provide informed consent.

Who cannot participate: Patients with certain heart conditions other than irregular heartbeat, those outside the specified age range, and vulnerable populations.

What the study tests: One group takes amiodarone for one month before the procedure, while another group takes it for only five days. Both groups aim to restore normal heart rhythm through medication combined with electrical cardioversion if needed.

Main goals: To determine which treatment duration is more effective in helping the heart return to normal rhythm and maintaining that rhythm for a month after the procedure.

Study on Amiodarone Hydrochloride for Treating Atrial Fibrillation in Critically Ill Patients

This Danish study focuses on critically ill patients in intensive care who develop new irregular heartbeats and need help breathing with a machine.

Who can participate: Adults 18 years or older in intensive care who are mechanically ventilated, have received a single dose of intravenous amiodarone for new irregular heartbeat, and have normal stomach function.

Who cannot participate: Patients who are not critically ill and mechanically ventilated, those without new irregular heartbeat, or those outside the specified criteria.

What the study tests: The trial compares giving amiodarone through an IV line directly into the bloodstream versus administering it through a feeding tube into the stomach. Researchers measure medication levels in blood, lung fluid, and breath samples.

Main goals: To understand which method of giving amiodarone works better in critically ill patients, potentially improving treatment outcomes for irregular heartbeats in intensive care settings.

Study on Apixaban for Preventing Stroke in Patients with Atrial Fibrillation and Stage 5 Chronic Kidney Disease

This multi-country study (Sweden, Poland, Norway, Finland, Iceland, Netherlands) examines whether apixaban can safely prevent strokes in people with irregular heartbeats who also have severe kidney disease.

Who can participate: Adults 18 years or older with irregular heartbeat and severe kidney disease requiring dialysis or with very low kidney function. Participants must have a high stroke risk based on medical scoring and provide informed consent. Women of childbearing age must use effective birth control and have a negative pregnancy test.

Who cannot participate: People with history of bleeding in the skull, high risk of fatal bleeding, inability to follow study procedures, pregnant or breastfeeding women, and those participating in other trials simultaneously.

What the study tests: Participants receive either apixaban (a blood thinner) or no anticoagulant treatment. The medication is taken as 2.5 mg tablets twice daily for up to 72 weeks while being closely monitored for strokes and bleeding events.

Main goals: To determine if apixaban can reduce stroke risk without causing dangerous bleeding in people with both irregular heartbeat and severe kidney disease.

Study on Atorvastatin’s Effect on Preventing Atrial Fibrillation in Patients Undergoing Surgical Aortic Valve Replacement

This Danish study investigates whether atorvastatin, a cholesterol-lowering medication, can prevent irregular heartbeats after heart valve replacement surgery.

Who can participate: Adults over 60 years old undergoing planned heart valve replacement surgery with a biological valve, currently in normal heart rhythm, and not taking heart rhythm medications except beta-blockers.

Who cannot participate: Patients not undergoing the specific valve surgery, those with pumping ability below 35%, or those with ongoing heart muscle damage.

What the study tests: Patients start taking atorvastatin 80 mg daily at least 7-14 days before surgery and continue until 30 days after surgery. Heart rhythm is monitored using a Holter device to detect irregular beats.

Main goals: To see if atorvastatin can prevent irregular heartbeats that commonly occur after heart valve surgery, while monitoring for side effects including thyroid function, liver function, and heart rhythm changes.

Study on Colchicine for Reducing Atrial Fibrillation Recurrence in Patients Undergoing Electrical Cardioversion

This Danish study examines whether colchicine, an anti-inflammatory medication, can prevent irregular heartbeats from returning after a procedure to restore normal heart rhythm.

Who can participate: Adults over 18 years old with irregular heartbeat confirmed by ECG, scheduled for or having had successful electrical cardioversion. Female participants must either be unable to have children or use effective birth control. All participants must be on the best treatment for their condition and willing to follow study requirements.

Who cannot participate: Patients with a history of irregular heartbeat or irregular heart flutter.

What the study tests: Participants receive either colchicine or placebo for up to 12 months after electrical cardioversion. The medication is taken orally as tablets with regular monitoring for heart rhythm and any side effects.

Main goals: To determine if colchicine can extend the time before irregular heartbeat returns, reduce hospital readmissions for symptoms, and improve heart function and quality of life.

Study on Dapagliflozin for Reducing Atrial Fibrillation and Kidney Injury in Patients Awaiting Coronary Artery Bypass Surgery

This tri-country study (Denmark, Sweden, Czechia) investigates whether dapagliflozin can reduce complications after heart bypass surgery.

Who can participate: Adults 18 years or older scheduled for coronary artery bypass surgery, possibly with additional procedures like valve replacement or repair. Participants must provide written consent.

Who cannot participate: People with recent heart attack, severe liver or kidney disease, active bleeding or high bleeding risk, uncontrolled high blood pressure, pregnancy or breastfeeding, recent major surgery, or certain types of cancer.

What the study tests: Participants receive either dapagliflozin 10 mg tablets or placebo taken once daily during hospital stay after surgery. Heart rhythm and kidney function are monitored closely throughout hospitalization and for 12 months afterward.

Main goals: To evaluate whether dapagliflozin can prevent new irregular heartbeats and acute kidney injury after bypass surgery, while monitoring for heart failure, stroke, and overall safety.

Study on Edoxaban and Drug Combination for Patients with Atrial Fibrillation Needing Anticoagulation After Cardiac Surgery

This German study compares different blood-thinning medications in people who develop irregular heartbeats after heart surgery.

Who can participate: Adults 18 years or older who had open heart surgery within the last 10 days and developed significant irregular heartbeat requiring blood-thinning medication. Participants must provide informed consent.

Who cannot participate: Patients with irregular heartbeat lasting longer than 30 seconds.

What the study tests: Participants receive either Direct Oral Anticoagulants (including edoxaban, apixaban, dabigatran, or rivaroxaban) or traditional Vitamin K Antagonists (warfarin or phenprocoumon). All medications are taken orally for 90 days with close monitoring.

Main goals: To compare safety and effectiveness of newer blood thinners versus traditional ones in preventing strokes and blood clots while monitoring for major bleeding events. The study also assesses quality of life and patient satisfaction with treatment.

Summary

These 10 clinical trials represent diverse approaches to managing atrial fibrillation and its complications across Europe. Several notable patterns emerge from this overview:

Geographic distribution: Denmark hosts the most trials among the first 10, with 4 studies, reflecting strong cardiovascular research infrastructure in Scandinavian countries. Studies are also prominent in Italy, Poland, and Spain, indicating widespread European engagement in atrial fibrillation research.

Medication focus: Blood thinners (anticoagulants) dominate the research landscape, with multiple studies examining medications like apixaban, rivaroxaban, edoxaban, and warfarin. Several trials investigate heart rhythm control medications including amiodarone, flecainide, and the experimental drug AP31969.

Patient populations: Many trials focus on high-risk patients including those with severe kidney disease, those undergoing heart surgery, and critically ill patients. Several studies specifically address patients who cannot take traditional blood thinners due to bleeding risks.

Treatment approaches: The trials examine diverse strategies from comparing single versus dual medication therapy to testing optimal timing and duration of treatments. Several studies investigate whether established medications can be repurposed for atrial fibrillation prevention.

These ongoing trials aim to improve outcomes for patients with atrial fibrillation by finding safer and more effective treatment approaches tailored to different patient populations and clinical situations.

Ongoing Clinical Trials on Atrial fibrillation

  • Study of AP31969 compared to placebo to control heart rhythm in patients with atrial fibrillation

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Denmark Germany Hungary Italy The Netherlands +1

  • Study of drug combination therapy for prevention of recurrent stroke in patients with acute ischemic stroke and atrial fibrillation

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany The Netherlands Spain

  • Evaluation of a Single Measurement Strategy for Direct Oral Anticoagulants in Frail Older Patients with Atrial Fibrillation or Venous Thromboembolism

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study of Allopurinol to Reduce Cardiovascular Events in High-Risk Patients with Heart Disease and Long-COVID Syndrome

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Study on Preventing Blood Clots in Patients with New-Onset Post-Operative Atrial Fibrillation after CABG Using Apixaban and Drug Combination

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Preventing Atrial Fibrillation Recurrence After Cardioversion Using Dapagliflozin in Patients

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • Study on Amiodarone for Patients with Persistent Atrial Fibrillation Undergoing Electrical Cardioversion

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Aspirin and Clopidogrel for Patients with Atrial Fibrillation After Left Atrial Appendage Closure

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Safety and Effectiveness of Apixaban and Warfarin for Patients with End-Stage Renal Disease on Peritoneal Dialysis and Atrial Fibrillation

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Edoxaban and Drug Combination for Patients with Atrial Fibrillation Needing Anticoagulation After Cardiac Surgery

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

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