Phase 3 Atrial Fibrillation Trial, Recruiting NCT03243175 Sponsor: University Hospital, Lille Condition: Atrial Fibrillation
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Phase 3 Atrial Fibrillation Trial, Recruiting

NCT03243175
Recruiting Phase 3

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 are 18 years of age or older (there is no upper age limit for the general trial)
  • People who have a history of a type of irregular heartbeat called atrial fibrillation (paroxysmal, persistent, or long-standing), confirmed by a heart tracing (ECG)
  • People whose atrial fibrillation-related stroke risk score (called CHA2DS2VASc) is 2 or higher, meaning long-term blood thinning treatment has been recommended for them
  • People who have had a bleed inside the brain (intracerebral haemorrhage) — whether or not they were on blood thinners at the time — confirmed by a brain scan (CT or MRI)
  • People whose brain bleed occurred more than 14 days before joining the trial (there is no maximum time limit after the bleed)
  • People where there is genuine uncertainty among their medical team about the best approach to prevent future strokes or vascular events

Who may not be able to join:

  • People who have significant disability before joining the trial, rated 4 or 5 on a standard disability scale (the modified Rankin Scale)
  • People who need long-term blood thinners for a reason other than atrial fibrillation, such as having a mechanical heart valve
  • People who have had a serious bleeding event (other than a brain bleed) in the 6 months before joining the trial
  • People whose life expectancy is less than 1 year
  • People who are pregnant or breastfeeding
  • People being considered for the heart procedure arm of the trial (called Left Atrial Appendage Closure, or LAAC) who have certain physical or anatomical reasons that make the procedure unsuitable, such as a blood clot in a specific part of the heart, or a current infection risk (confirm with trial site)
  • People being considered for the LAAC procedure arm who are older than 85 years
  • People being considered for the LAAC procedure arm whose stroke risk score (CHA2DS2VASc) is only 2 or 3
  • People being considered for the LAAC procedure arm where either the patient or their doctor is unwilling to proceed with that procedure
  • People being considered for the blood-thinning medication arm who have severe kidney problems (confirm with trial site for specific test values)
  • People being considered for the blood-thinning medication arm who weigh less than 50 kg
  • People being considered for the blood-thinning medication arm who have an allergy to the medication apixaban
  • People being considered for the blood-thinning medication arm who have conditions that make falls or head injuries more likely, such as balance problems or uncontrolled seizures
  • People being considered for the blood-thinning medication arm where either the patient or their doctor is unwilling to use that type of medication

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 14 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Charlotte Cordonnier, MD, PhD, University Hospital Lille, Inserm, Univ Lille

Phone: 3 20 44 68 14

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 3
Registry
ClinicalTrials.gov
Start date
17 January 2019
Est. completion
1 January 2029

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Composite of all fatal or non-fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events

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: 14 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