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Completed

NCT Number: NCT03702582

Rivaroxaban vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation

This prospective, randomized, active-controlled, parallel arm study compares the safety and financial benefits of arterial thromboembolism prophylaxis with Warfarin vs. Rivaroxaban (A novel oral anticoagulant) in patients with new onset atrial fibrillation after sternotomy for cardiac operations.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Bleeding Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Hemorrhage Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

New onset atrial fibrillation (NOAF) is a common occurrence following cardiac surgery, occurring in 20-30% of patients post-operatively. Historically, Vitamin K antagonist therapy with Warfarin has been the treatment of choice for prophylaxis against stroke and systemic arterial thromboembolism in NOAF. Warfarin inhibits the Vitamin K dependent factors involved in both the intrinsic and extrinsic coagulation cascades, thus decreasing systemic clotting. However, Warfarin therapy comes with many challenges including prolonged titration, tedious monitoring requirements and in some cases, increased bleeding risk.

The limitations associated with Warfarin may be mitigated by using new oral anticoagulants (NOACs) like Rivaroxaban which have no routine monitoring requirements. Rivaroxaban is a direct inhibitor of Factor Xa, a central reactant in both the intrinsic and extrinsic coagulation cascades. Studies in non-operative patients with atrial fibrillation have shown that Rivaroxaban is non-inferior to Warfarin for stroke prophylaxis with similar risk profiles. This study aims to compare the efficacy, safety and financial cost of these two drugs when used for the management of new onset atrial fibrillation that occurs after cardiac operations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female ≥ 18 years
  • At least one of the following procedures: coronary artery bypass grafting, aortic valve repair, mitral valve repair, non-mechanical aortic valve replacement, any combination of these procedures
  • Two or more episodes of New Onset Atrial Fibrillation (each lasting > 20 minutes) or persistent atrial fibrillation lasting > 24 hours (Or for >18 hours over a 24-hour interval)
  • If female of child-bearing age, use of adequate contraception

Exclusion criteria

  • Pre-existing paroxysmal atrial fibrillation before cardiac surgery
  • Pre-existing indications for therapeutic anticoagulation (Including but not limited to PE, DVT, mechanical valve)
  • Moderate-to-severe mitral valve stenosis not surgically corrected
  • Pre-existing allergy to study medications
  • Recent (< 1 year) or ongoing pregnancy (Urine pregnancy test will be obtained for women of child bearing age at the time of enrollment into the study)
  • Stroke within 1 month prior to surgery or postoperatively prior to initiation of study drugs
  • Postoperative bleeding episode prior to initiation of study drug
  • Severe dysfunction of another organ system including GFR < 30 ml/min, baseline INR > 1.7, ileus or other gastrointestinal pathology hindering ability to absorb oral medications, and known coagulation pathway deficiencies
  • Postoperative need for non-aspirin anti-platelet therapy that cannot be discontinued when therapeutic anticoagulation is initiated
  • Patient taking medications with known major interactions with study drugs with no therapeutic alternatives)

Treatment and study plan

Rivaroxaban

Drug

Anticoagulant drug that works via direct inhibition of factor Xa. FDA approved for prophylaxis against stroke in non-valvular atrial fibrillation

Other names: Xarelto, Database of Molecules (PubChem CID): 6433119

Warfarin

Drug

Anticoagulation drug that works via inhibition of vitamin K dependent clotting factors. FDA approved for prophylaxis against stroke in atrial fibrillation

Other names: Coumadin, Database of Molecules (PubChem CID): 54678486

Primary outcomes

  1. Postoperative Length of Stay

    Time frame: Up to 6 months following the cardiac operation

    Length of inpatient stay in days from time of departure from the operating room

Secondary outcomes

  1. Episode of Major Bleeding (Defined as the Occurrence of Any of Several Events Listed in the Description. No Specific Scale, Questionnaire or Instrument Will be Used)

    Time frame: Up to 30 days after discharge from the initial postoperative hospitalization

    Major bleeding defined as re-operation or other therapeutic intervention for bleeding (including but not limited to colonoscopy, upper endoscopy and urologic procedures for hematuria), development of any intracranial bleeding, cessation of study drug for bleeding concerns, reversal of study drug for bleeding concerns and/or new transfusion requirement > 2 units of blood after drug administration

  2. Cerebrovascular Accident (CVA)

    Time frame: Up to 30 days after discharge from the initial postoperative hospitalization

    Rates of cerebrovascular accident including stroke and transient ischemic attack (TIA)

  3. Other Systemic Embolism

    Time frame: Up to 30 days after discharge from the initial postoperative hospitalization

    Rates of non-neurological systemic arterial embolism involving any organ system

  4. Deep Venous Thrombosis (DVT) and/or Pulmonary Embolism (PE)

    Time frame: Up to 30 days after discharge from the initial postoperative hospitalization

    Occurrence of pathologic venous thrombo-embolism including DVT and PE

  5. Minor Bleeding

    Time frame: Up to 30 days after discharge from the initial postoperative hospitalization

    Minor bleeding defined as blood transfusions <= 2 units or drop in hemoglobin greater 3g/dL following administration of study drugs

  6. Performance on the EUROQOL (EQ-5D) Quality of Life Instrument

    Time frame: Up to 30 days after discharge from the initial postoperative hospitalization

    Participants will be administered the EUROQOL-5D-3L (5 dimensions, 3 levels) questionnaire to derive an estimate of the health state. This is comprised of a 5 questions survey and a single visual analog scale highlighting perceived health levels

    For the 5 questions survey, each question related to mobility, selfcare, mood, pain and/or functionality is answered on a three point scale with higher number representing worse outcomes. The entire dataset is used to generate a health state based on the unique pattern of answers. These health states are then compared against standardized country-based value sets which provide an assessment of quality of life based on societal preferences.

  7. Performance on the EUROQOL (EQ-5D) Quality of Life Instrument - VAS

    Time frame: Up to 30 days after discharge from the initial postoperative hospitalization

    Participants will be administered the EUROQOL-5D-3L (5 dimensions, 3 levels) questionnaire to derive an estimate of the health state. This is comprised of a 5 questions survey and a single visual analog scale highlighting perceived health levels

    For the 5 questions survey, each question related to mobility, selfcare, mood, pain and/or functionality is answered on a three point scale with higher number representing worse outcomes. The entire dataset is used to generate a health state based on the unique pattern of answers. These health states are then compared against standardized country-based value sets which provide an assessment of quality of life based on societal preferences.

    The visual analog scale is single answer between 0 and 100 representing the patient's perception of their health state. 0 represents the worst health imaginable and 100 represents the best.

  8. Average Score on the Perception of Anticoagulant Treatment Questionnaire (PACT-Q2)

    Time frame: Up to 30 days after discharge from the initial postoperative hospitalization

    Participants will be administered the PACT-Q2 questionnaire which is comprised of a convenience subscale and a satisfaction subscale.

    For the convenience subscale, each of 13 questions is answered on a 1-5 rating scale with higher numbers representing worse outcomes. A sub-scale score is generated by inverting the score from each element and calculating the sum. Range on the inverted scale is 13 - 65. Higher scores represent better outcomes.

    For the satisfaction subscale, each of 7 questions is answered on a 1-5 rating scale with higher numbers representing better outcomes. The total score on this subscale is generated by adding up scores from all elements. Range on this subscale is 7-35. Higher scores represent better outcomes.

    A composite score is generated by adding up scores from both subscales and recalibrating on a 0-100 scale by adding the scores together and applying the formula: COMPOSITE SCORE=100×(Sum-20)/80. Higher scores represent more favorable outcomes.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Trial of New Oral Anticoagulants vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation

Acronym: NEW-AF

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 11, 2018
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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