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

Conditions

• Atrial Fibrillation
• Bleeding
• Stroke

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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)

Study Details

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.

Key Dates

Start date

Dec 13, 2019

Status verified

Jan 2026

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

3,200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Antiplatelet Therapy
  Antiplatelet-only strategy
• Active Comparator: Oral Anticoagulant
  OAC-based strategy

Primary Outcome Measure

Composite of death, ischemic stroke, TIA, MI, systemic arterial thromboembolism or venous thromboembolism (DVT and/or PE) [ Time Frame: up to 180 days after randomization ]

Central Contacts

• Ellen Moquete, RN
  212-659-9651
  [email protected]

Locations (51)

Find similar trials in Little Rock, AR

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