Phase 4 Atrial Fibrillation Trial, Recruiting NCT04695106 Sponsor: Medical University of Gdansk Condition: Atrial Fibrillation
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Phase 4 Atrial Fibrillation Trial, Recruiting

NCT04695106
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:

  • You must be 18 years old or older, either male or female.
  • You must have an irregular heart rhythm called atrial fibrillation (AF), which is not caused by a temporary or reversible condition (such as a recent heart attack, blood clot in the lungs, recent surgery, or thyroid problems), unless your doctor plans to keep you on blood thinners long-term.
  • You must have already been taking a blood-thinning medication called dabigatran for at least 48 hours before joining, or have not been on any blood thinner before your heart procedure.
  • You must have recently had a heart procedure called PCI (a procedure to open blocked heart arteries) using a drug-coated stent or balloon, within the past 120 hours, after experiencing a heart attack or severe chest pain (unstable angina), and the procedure must have been considered successful by your doctors.
  • You must be able to understand and sign a consent form agreeing to take part in the trial.

Who may not be able to join:

  • You have an artificial or biological heart valve.
  • Your PCI procedure used a bare-metal stent (a type of stent without a drug coating).
  • Your PCI procedure was not fully successful (a significant blockage was still present afterward).
  • You went into severe heart failure (cardiogenic shock) during your current hospital stay.
  • You had a serious bleeding or a blood-flow-related event during your current hospital stay.
  • You have low red blood cell levels (anaemia) or a low platelet count (cells that help blood clot) at the time of screening.
  • Your kidneys are working very poorly (confirm with trial site for specific kidney function thresholds).
  • You have active liver disease, shown by significantly elevated liver enzyme levels in your blood tests at screening.
  • You were given clot-dissolving medications within 24 hours before screening.
  • You had bleeding in your stomach or gut within the past month, unless your doctor is confident the cause has been permanently fixed.
  • You had a major or life-threatening bleeding episode within the past month, including bleeding in the brain or bleeding requiring a significant blood transfusion or surgery.
  • You had a stroke within the past month.
  • You had major surgery within the past month.
  • You have or recently had cancer, or received radiation therapy within the past 6 months, unless your doctor expects you to live for more than 3 years.
  • You have a history of bleeding inside the eye, spine, abdomen, or joints from injury, unless the cause has been permanently corrected.
  • You have a bleeding disorder, such as haemophilia or von Willebrand disease, or a history of prolonged or spontaneous bleeding.
  • You have had an organ transplant in the past, or are currently on a waiting list for one.
  • You need to continue taking certain medications that can interfere with the study drugs, including some antifungal, anti-seizure, immunosuppressant, or herbal medicines (such as St. John's Wort) — confirm the full list with the trial site.
  • You need to keep taking anti-inflammatory pain relief medicines (such as ibuprofen or naproxen) on an ongoing basis.
  • You are a woman who has had a period within the last year and are pregnant, breastfeeding, or not using at least two reliable methods of contraception throughout the trial (certain contraception methods are specified — confirm with trial site).
  • You have a known allergy to any of the study medications: dabigatran, ticagrelor, clopidogrel, or aspirin, or to any of their ingredients.
  • Your doctor believes any of the study medications are not suitable for you for medical reasons.
  • You have taken part in another clinical trial involving an experimental drug or device within the past 30 days (taking part in an observational study only is acceptable).
  • You are unable or unwilling to follow the trial rules, attend follow-up visits, take the study medication as directed, have a serious illness that may affect your ability to complete the trial, or have any other condition that your doctor feels would make participation unsafe (such as drug or alcohol dependency).

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 5 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

Phone: 791445345

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
Medical University of Gdansk
Registry
ClinicalTrials.gov
Start date
25 October 2021
Est. completion
11 July 2026

Where this trial is recruiting

🇵🇱 Poland

Primary endpoints

Primary safety endpoint - first major or clinically relevant non-major bleeding event, as defined by the ISTH

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: 5 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