Phase 4 Atrial Fibrillation Trial, Recruiting NCT05955365 Sponsor: Insel Gruppe AG, University Hospital Bern Condition: Atrial Fibrillation
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Phase 4 Atrial Fibrillation Trial, Recruiting

NCT05955365
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older
  • People who have atrial fibrillation or atrial flutter and whose doctor has determined they need to take a type of blood thinner called a direct-acting oral anticoagulant (DOAC) for at least 12 months
  • People who have had a successful procedure to open blocked heart arteries (using a small tube called a stent, inserted through the skin) within the past 7 days, with no other blocked arteries left that still need to be treated
  • People who have not experienced serious complications after that procedure, such as new chest pain thought to be related to the heart, a blocked stent, or new stroke-like symptoms
  • People who have given written agreement to take part in the trial

Who may not be able to join:

  • People who have another planned procedure to open blocked heart arteries (a valve procedure may be allowed if it takes place more than 30 days after the qualifying heart procedure)
  • People who have had a procedure to reset their heart rhythm (cardioversion) in the past month, or who have one planned
  • People who have had a procedure to treat their atrial fibrillation using heat or cold energy (ablation) in the past 2 months, or who have one planned
  • People who have previously had an artificial mechanical heart valve implanted
  • People who have a blood clot in the leg or lung, a significant narrowing of a heart valve called the mitral valve, or another condition (besides atrial fibrillation) that requires long-term blood thinners
  • People who have had a stroke in the past month
  • People whose blood pressure is dangerously low, who need continuous medication to keep the heart pumping, or who require a mechanical device to help the heart work
  • People with very high uncontrolled blood pressure (top number at or above 180 mmHg and/or bottom number at or above 120 mmHg)
  • People with very poor kidney function or who are on dialysis
  • People with moderate or severe liver disease, or any liver condition that affects blood clotting
  • People who are known to be allergic to or cannot safely take blood thinners or antiplatelet medications (such as aspirin or a related drug called a P2Y12 inhibitor)
  • People with very low platelet counts or very low haemoglobin levels on recent blood tests
  • People who are pregnant or breastfeeding
  • People with another serious non-heart condition where life expectancy is less than one year
  • People who have planned surgery, including open-heart bypass surgery, within the next 6 months

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Stephan Windecker, Prof, Bern University Hospital, Department of Cardiology

Phone: +41 31 632 44 97

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Insel Gruppe AG, University Hospital Bern
Registry
ClinicalTrials.gov
Start date
18 December 2023
Est. completion
31 December 2027

Where this trial is recruiting

🇧🇪 Belgium 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇱 Poland 🇪🇸 Spain 🇨🇭 Switzerland 🇬🇧 United Kingdom

Primary endpoints

The number of participants with a major adverse cardiac or cerebral events (MACCE), defined as the composite of death from any cause, myocardial infarction, stroke or non-central nervous system (non-CNS) systemic embolism; The number of participants with a major or clinically relevant non-major bleeding (MCB), defined according to the International Society of Thrombosis and Haemostasis (ISTH) criteria

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov