Health TrialsbyHealthPanel

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG

ConditionsAtrial FibrillationStrokeBleeding
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Clinical history of either permanent, persistent or paroxysmal atrial fibrillation

Any pre-existing clinical indication for long-term OAC

Any absolute contraindication to OAC

Planned use of post-operative dual antiplatelet therapy (DAPT)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

3,200 Participants
are divided into 2 treatment groups
Group A: Antiplatelet TherapyActive comparator 1 intervention
Group B: Oral AnticoagulantActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

Number of participants with Ischemic Stroke event

Time frame
180 days after randomization
3

Number of participants with TIA event

Time frame
180 days after randomization
4

Number of participants with MI event

Time frame
180 days after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Vanderbilt University Medical Center

Collaborator

Source ClinicalTrials.gov
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