At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Antiplatelet-only strategy (drug), Oral Anticoagulant plus background antiplatelet therapy (drug)
- How long the study runs
- Study runs about 80 months (dates as stated)
- About the drug or intervention
- Antiplatelet-only strategy — drug: Aspirin 75-325 mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor) · Oral Anticoagulant plus background antiplatelet therapy — drug: 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)
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at adults who develop a fast, irregular heartbeat called atrial fibrillation (AF) for the first time after heart bypass surgery known as coronary artery bypass grafting (CABG). AF can raise the risk of stroke and bleeding, so the trial is studying whether blood-thinning medicines (anticoagulants) should be used in this situation. The sponsor is the Icahn School of Medicine at Mount Sinai.
Who can take part
- Adults aged 18 or over who have CABG surgery alone for coronary artery disease
- People whose post-operative atrial fibrillation (AF after surgery) lasts more than 60 minutes or comes back more than once within 7 days of the surgery
Who may not be able to
- Anyone who already had atrial fibrillation (permanent, persistent, or paroxysmal) before
- Anyone who already needs long-term blood-thning medicine (oral anticoagulants) for another reason, or who cannot take them
- People planned to have two antiplatelet medicines together after surgery (dual antiplatelet therapy), for example after a recent stent procedure
- People who had cardiogenic shock (the heart cannot pump enough blood)
- People who had a major problem around the time of surgery, such as stroke, mini-stroke (TIA), heart attack, major bleeding, severe infection, kidney failure needing dialysis, or another operation for bleeding
- People who had other heart procedures at the same time as the CABG, such as closing off part of the left atrium, valve surgery or repair, carotid artery surgery, aortic root replacement, or surgery for AF
- People with severe liver disease (cirrhosis or Child-Pugh Class C)
- People who took an experimental drug or device within 30 days before joining, or who plan to join another experimental trial during this one
- Women who are pregnant when the trial starts
- People unable or unwilling to give informed consent or to follow the treatment and follow-up plan
- People with another illness expected to shorten life to less than one year
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about visits, duration, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 3,200
- Started
- 2019-12-13
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for atrial fibrillation
- • Phase3 - 3,200 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with atrial fibrillation
Where?
- • Liverpool - Liverpool Heart and Chest Hospital NHS Foundation Trust
- • London - Barts Health NHS Trust
- • London - Imperial College Healthcare NHS Trust
- • Wolverhampton - Royal Wolverhampton NHS Trust
- • +13 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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: * OAC-based strategy (experimental arm): OAC with vitamin K antagonist (VKA) with international normalized ratio (INR) target 2-3 or any approved direct oral anticoagulant (apixaban, rivaroxaban, edoxaban or dabigatran) in addition to background antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor) * Antiplatelet-only strategy (control arm): single antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor) 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Patients of age ≥18 years who undergo isolated CABG for coronary artery disease
- ✓POAF that persists for \>60 minutes or is recurrent (more than one episode) within 7 days after the index CABG surgery
Who cannot take part
- ✗Clinical history of either permanent, persistent or paroxysmal atrial fibrillation
- ✗Any pre-existing clinical indication for long-term OAC
- ✗Any absolute safety concern to OAC
- ✗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.
See the full criteria
Where Is This Study? (17 UK sites)
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom
Belfast Health and Social Care Trust
Belfast, United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol BS1 3NU, United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom
Hull University Teaching Hospitals NHS Trust
Cottingham HU16 5JQ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351South Tees Hospitals NHS Foundation Trust
Middlesbrough, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford OX3 9DU, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
University Hospitals Sussex NHS Foundation Trust
Worthing BN11 2DH, United Kingdom
How to Get in Touch
Jonathan Hupf
Sponsor contactCONTACT