Phase 3 Stroke Trial, Recruiting NCT04045665 Sponsor: Icahn School of Medicine at Mount Sinai Condition: Stroke
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Phase 3 Stroke Trial, Recruiting

NCT04045665
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:

  • Adults aged 18 or older who have had heart bypass surgery (CABG) on its own, not combined with other procedures
  • People who develop a type of irregular heart rhythm called atrial fibrillation after their bypass surgery, where the irregular rhythm either lasts more than 60 minutes or happens more than once within 7 days after surgery

Who may not be able to join:

  • People who have a history of atrial fibrillation (irregular heart rhythm) of any kind before their surgery
  • People who already have a medical reason to take long-term blood thinning medication
  • People for whom blood thinning medication is medically not safe to use at all
  • People who are planned to take two types of blood thinning tablets together (called dual antiplatelet therapy) after surgery — this includes people who recently had a heart stent procedure
  • People who are in a state of severe heart failure (cardiogenic shock)
  • People who experience a serious complication between their bypass surgery and the point of joining the trial — this includes stroke, mini-stroke (TIA), heart attack, major bleeding, severe infection, kidney failure requiring dialysis, or needing a second operation due to bleeding
  • People who had their left atrial appendage (a small pouch in the heart) closed during their bypass surgery
  • People who had heart valve surgery at the same time as, or before, their bypass surgery (including the aortic, mitral, tricuspid, or pulmonary valves)
  • People who had a mitral valve repair procedure during their bypass surgery
  • People who had a carotid artery operation in the neck at the same time as their bypass surgery
  • People who had the main blood vessel from the heart (aortic root) replaced during their bypass surgery
  • People who had additional surgery specifically for atrial fibrillation during their bypass surgery
  • People with liver cirrhosis or severe chronic liver disease (confirm with trial site)
  • People who have taken an experimental drug or used an experimental medical device within the 30 days before joining the trial, or who plan to join another experimental treatment trial at the same time
  • People who are pregnant at the time of joining the trial
  • People who are unable or unwilling to give their informed consent to participate
  • People who are unable or unwilling to follow the study treatment plan and attend follow-up appointments
  • People with an existing illness that means their life expectancy is less than one year

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 19 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: Annetine C Gelijns, PhD, Icahn School of Medicine at Mount Sinai

Phone: (212) 659-6862

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
13 December 2019
Est. completion
31 August 2026

Where this trial is recruiting

🇧🇷 Brazil 🇨🇦 Canada 🇩🇪 Germany 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Composite of death, ischemic stroke, TIA, MI, systemic arterial thromboembolism or venous thromboembolism (DVT and/or PE); Any BARC type 3 or 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: 19 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