A Phase 3 interventional study of Antiplatelet-only strategy and Oral Anticoagulant plus background antiplatelet therapy in Atrial Fibrillation, Stroke and Bleeding, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 106 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 3, Interventional, and Treatment
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Among 993 studies in Atrial Fibrillation with a site in United States — 161 open to participants now, 220 under way, 15 of them phase 3. Atrial Fibrillation · United States.
Among the 993 studies in Atrial Fibrillation with a site in United States, this one is the 37th largest by planned enrollment of the 679 interventional ones that give a count, is one of 58 that started in 2019, is one of 100 in phase 3, reaches primary completion later than 54 of the 219 other live ones, and was the 600th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.
Browse Atrial Fibrillation studies →161 of the 993 studies in Atrial Fibrillation with a site in United States are open now. Recruiting first, the newest first:
Kardium Inc. · Sites in United States
Ages 18+
Boston Scientific Corporation · Sites in United States
Ages 18+
Bayer · Sites in United States, Belgium, Bulgaria and 5 more countries
Ages 18–85
Texas Cardiac Arrhythmia Research Foundation · Sites in United States
Ages 18+
Oslo University Hospital · Sites in United States, Belgium, France and 7 more countries
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
993 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 30 · Phase 2 71 · Phase 3 107 · Phase 4 87
First in 1989; this study’s year is marked. 58 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 3,200 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Median enrollment 127 across the 679 interventional studies, 200 across the 308 observational. Of the 675 that completed or were terminated, 304 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
349 of 993 have an industry lead sponsor. The 10 most frequent:
Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Icahn School of Medicine at Mount Sinai has 5 studies filed under Atrial Fibrillation — fewer than ten, so there is no comparison to draw.
74 of the studies in Atrial Fibrillation with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06376916Phase 3Wake Forest University Health SciencesComparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR | 2026-12 |
| NCT05757869Phase 3Janssen Research & Development, LLCA Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation | 2026-12-08 |
| NCT03907046Phase 3Yale UniversityAnticoagulation in ICH Survivors for Stroke Prevention and Recovery | 2027-04 |
| NCT05174052Phase 3University of OklahomaDapagliflozin in Patients With Atrial Fibrillation (DAPA-AF) | 2027-04 |
| NCT02750319Phase 3Memorial Sloan Kettering Cancer CenterAmiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery | 2027-04 |
Add all 74 to your calendar (.ics) → With an account.
Among the 993 studies in Atrial Fibrillation with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery.
All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey.
This is a prospective, multicenter, open-label, randomized trial comparing OAC with no OAC (1:1 ratio) in patients who develop new-onset POAF after CABG. The primary effectiveness endpoint is the composite of death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE) at 90 days after randomization. The primary safety endpoint is BARC (Bleeding Academic Research Consortium) grade 3 or 5 bleeding at 90 days after randomization. The overall intent is to evaluate the trade-off in prevention of thromboembolic events versus an increase in bleeding.
Patients will be randomly assigned to the following treatment strategies:
The protocol-specified duration of anticoagulation is 90 days. Patients, who are randomized to the control arm and develop recurrent AF after 30 days, may be crossed-over to an OAC. Accrual is expected to take 60 months. Study follow-up visits will be performed at 90 days and phone follow-up at days 30, 60, and 180 days.
Data for patients enrolled in the registry will be ascertained from the local clinical site via a review of medical records. The baseline risk profile of registry patients (i.e., patients eligible but unwilling to be randomized) will be analyzed and compared to that of patients randomized in the trial. The usage of anticoagulant and antiplatelet therapies in the registry population overall and baseline CHA2DS2-VASC ischemic stroke risk score will also be determined.
Up to 500 patients will also be offered the option to participate in a digital health substudy which includes a wearable heart rhythm monitor device for 30 days post discharge.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Planned use of post-operative dual antiplatelet therapy (DAPT)
a. This includes, but is not limited to, patients with recent PCI with drug-eluting or bare-metal stent.
Major perioperative complication* occurring between CABG and randomization
a. including, but not limited to, stroke, , MI, major bleeding (BARC type 4 bleeding), severe sepsis, renal failure requiring dialysis, or need for reoperation due to bleeding (e.g. pericardial tamponade).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Antiplatelet-only strategy
Drug: Antiplatelet-only strategy
OAC-based strategy
Drug: Oral Anticoagulant plus background antiplatelet therapy
Aspirin 75-325 mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
OAC with vitamin K antagonist (VKA) with international normalized ratio (INR) target 2-3 or any approved direct oral anticoagulant OR apixaban, rivaroxaban, edoxaban or dabigatran) in addition to background antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
Composite of death, ischemic stroke, TIA, MI, systemic arterial thromboembolism or venous thromboembolism (DVT and/or PE)
Composite score of death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (deep venous thrombosis and/or pulmonary embolism). Composite score calculated by number of events.
Time frame: up to 180 days after randomization
Any BARC type 3 or 5
The Bleeding Academic Research Consortium (BARC) - any type 3 or 5 bleeding thrombosis and/or pulmonary. Type 3: a. Overt bleeding plus hemoglobin drop of 3 to \< 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding b. Overt bleeding plus hemoglobin drop \< 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents c. Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision. type 5: a. Probable fatal bleeding b. Definite fatal bleeding (overt or autopsy or imaging confirmation)
Time frame: 90 days after randomization
Net clinical benefit (NCB)
Defined as the integration of the trial's primary effectiveness and safety endpoint to capture overall risk and benefit of anticoagulation. NCB will be assessed as a two-dimensional outcome with the observed NCB plotted versus effectiveness and safety, and a curve drawn. the confidence intervals will be compared to this curve.
Time frame: 90 days after randomization
Number of participants with Ischemic Stroke event
Time frame: 180 days after randomization
Number of participants with TIA event
Time frame: 180 days after randomization
Number of participants with MI event
Time frame: 180 days after randomization
Number of participants with systematic arterial thromboembolism event
Time frame: 180 days after randomization
Number of participants with venous thromboembolism event
Time frame: 180 days after randomization
Number of cardiovascular mortalities
Time frame: up to 180 days after randomization
Number of non-cardiovascular mortalities
Time frame: up to 180 days after randomization
The incidence of BARC 2 bleeding at 90 after randomization
BARC Type 2: Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional
Time frame: 90 days after randomization
The incidence of BARC 2 bleeding at 180 days after randomization
BARC Type 2: Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional
Time frame: 180 days after randomization
Number of cardiac arrhythmias
Number of cardiac arrhythmias including recurrent symptomatic or asymptomatic AF requiring medical attention
Time frame: 180 days after randomization
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Showing the first 100 of 106 sites across 5 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: OtherDe-identified study data sets must be submitted to the designated NHLBI Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the designated PO for review prior to release.
Access criteria: Anyone who wishes to access the data.Any purpose.Data are available indefinitely at (Link to be included).
Data sharing details ↗ · biolincc.nhlbi.nih.gov
Started Dec 2019 (actual). Primary completion is estimated for Aug 2026, 80 months after the start.
Of 62 non-industry phase 3 interventional studies under Atrial Fibrillation, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 73. This study's planned 80 months is above that.
Counting every sponsor, half of 83 studies reached it within 42 months; a quarter within 32 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Icahn School of Medicine at Mount Sinai →