Phase 4 Atrial Fibrillation Trial, Recruiting NCT04436978 Sponsor: St. Antonius Hospital Condition: Atrial Fibrillation
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Phase 4 Atrial Fibrillation Trial, Recruiting

NCT04436978
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 recently had a successful procedure to open blocked heart arteries (called PCI, either as an emergency or planned procedure)
  • People who have been diagnosed with an irregular heart rhythm called atrial fibrillation or atrial flutter — either previously or within 72 hours of the procedure — and who have a long-term need (at least 1 year) for blood-thinning medication

Who may not be able to join:

  • People who cannot take the blood-thinning medication edoxaban, aspirin, or all medications in the P2Y12 inhibitor group (a type of blood thinner)
  • People who need blood-thinning medication for a reason other than atrial fibrillation or flutter (for example, blood clots in the legs or lungs)
  • People who have had a stroke within the past 12 months
  • People with a very high score on a heart risk scale called CHADSVASc (score of 7 or above)
  • People with a moderate to severe narrowing of one of the heart valves (the mitral valve)
  • People who have an artificial mechanical heart valve
  • People with a blood clot inside the heart or a specific type of heart bulge requiring blood thinners
  • People with very poor heart pumping function combined with confirmed slow blood flow in the heart
  • People who have ever had bleeding inside the brain
  • People who are actively bleeding at the time of enrolment
  • People with a history of bleeding inside the eye, spine, abdomen area, or into a joint from an injury — unless the cause of that bleeding has been permanently fixed
  • People who have had a gastrointestinal bleed (such as stomach or bowel bleeding) within the past month, unless the cause has been permanently fixed
  • People with a known condition that affects blood clotting
  • People with severe anaemia needing a blood transfusion, or a very low platelet count (below 50 × 10⁹/L)
  • People with a BMI over 40, or who have had weight-loss (bariatric) surgery
  • People with severe kidney failure (eGFR below 15)
  • People with active liver disease or active hepatitis A, B, or C
  • People with an active cancer (excluding a common, low-risk type of skin cancer called non-melanoma skin cancer)
  • People with a life expectancy of less than 1 year
  • People who are pregnant or breastfeeding

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 7 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: Jurriën M ten Berg, Prof, MD, St. Antonius Hospital

Phone: +31 (0)88 320 0925

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
St. Antonius Hospital
Registry
ClinicalTrials.gov
Start date
11 January 2023
Est. completion
1 October 2027

Where this trial is recruiting

🇧🇪 Belgium 🇳🇱 Netherlands

Primary endpoints

Primary safety endpoint; Primary efficacy endpoint

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: 7 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