Phase 4 Atrial Fibrillation Trial, Recruiting NCT03445949 Sponsor: National Institute of Cardiology, Warsaw, Poland Condition: Atrial Fibrillation
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Phase 4 Atrial Fibrillation Trial, Recruiting

NCT03445949
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 who have recently had a successful procedure to close off a part of the heart called the left atrial appendage, using either an Amplatzer or WATCHMAN device, within the past 37 days before joining the study
  • People who have been taking two blood-thinning medications together — clopidogrel and aspirin — between that heart procedure and the start of the study
  • People who are 18 years of age or older at the time of signing the consent form
  • People who are willing to follow all study procedures, including taking the specific blood-thinning medication plan assigned by the study
  • People who are willing to sign the study's consent form

Who may not be able to join:

  • People who need to take both clopidogrel and aspirin together for a reason other than their irregular heart rhythm or the heart closure procedure — for example, those who have a planned heart artery procedure coming up
  • People who need to take blood-thinning medication (anticoagulation) for another medical reason at the time of joining, or who are expected to need it during the study — for example, due to a blood clot in the lungs
  • People who are known to be allergic to clopidogrel and/or aspirin in a way that would prevent them from taking these medications as required by the study
  • People who have any known blood clotting disorder, whether inherited or developed over time
  • People found to have a gap larger than 5mm around their heart device on a scan taken before joining the study
  • People found to have a blood clot in the upper left chamber of their heart on a scan taken after the closure procedure but before joining the study
  • People whose life expectancy is estimated to be less than 18 months
  • People who are currently taking part in, or have taken part in, another clinical study involving experimental treatments within the past 3 months
  • People with advanced kidney disease (classified as stage IV or V)
  • People who are pregnant or breastfeeding; also, women who could become pregnant and do not agree to use at least two methods of contraception during the study — this does not apply to women who are confirmed to be at least 2 years past menopause, or who have had a surgical procedure to prevent pregnancy (confirm with trial site for details on pregnancy testing requirements)

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 6 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: Radoslaw Pracon, MD PhD, Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland

Phone: 22 343 43 42

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
National Institute of Cardiology, Warsaw, Poland
Registry
ClinicalTrials.gov
Start date
23 January 2018
Est. completion
23 June 2025

Where this trial is recruiting

🇵🇱 Poland

Primary endpoints

Efficacy (a composite of ischemic stroke, transient ischaemic attack, peripheral embolism, nonfatal myocardial infarction, cardiovascular mortality, all-cause mortality, left atrial appendage thrombus); Safety (moderate and/or severe bleeding (BARC type 2, 3, and 5)

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: 6 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