BRIDGE: Bridging Anticoagulation in Patients who Require Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

BRIDGE: Bridging Anticoagulation in Patients who Require Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery

Description

1) To compare the efficacy of bridging anticoagulation (therapeutic-dose LMWH) with no bridging anticoagulation (placebo) on the rate of ATE in patients with atrial fibrillation or atrial flutter who require temporary interruption of warfarin.

2) To compare the safety of bridging anticoagulation with no bridging anticoagulation on the rate of major bleeding in patients who require temporary interruption of warfarin

Patient Inclusion Criteria:
Inclusion criteria - All of the following 5 criteria must be satisfied for trial eligibility:

  • adult male or female, age 18 years or older
  • receiving warfarin therapy (for at least 3 months), administered to achieve a target INR range of 2.0-3.0
  • require temporary interruption of warfarin for pre-specified elective procedure or surgery
  • have at least one of the following conditions: (a) chronic (permanent or paroxysmal) nonvalvular atrial fibrillation or atrial flutter, confirmed by at least one prior electrocardiography recording or pacemaker/ACD interrogation; or (b) chronic (permanent or paroxysmal) valvular atrial fibrillation or atrial flutter with evidence of mitral valvular heart disease, confirmed by same criteria as nonvalvular atrial fibrillation or atrial flutter
  • have at least one of the following major stroke risk factors: (a) age >75 years; (b) hypertension; (c) diabetes mellitus; (d) congestive heart failure or left ventricular dysfunction; or (e) previous ischemic stroke, systemic embolism or TIA

Patient Exclusion Criteria:
One or more of the following criteria precludes trial eligibility:

  • any mechanical prosthetic heart valve
  • stroke (ischemic or hemorrhagic), systemic embolism or TIA within past 12 weeks
  • venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) within past 12 weeks.
  • major bleeding within past 6 weeks
  • severe renal insufficiency (calculated creatinine clearance <30 mL/min)
  • thrombocytopenia (platelet count <100 × 109/L)
  • life expectancy <1 month
  • condition that impairs compliance with trial protocol (e.g., cognitive impairment, uncontrolled psychiatric condition, geographic inaccessibility)
  • pregnancy (AND OTHERS)

Details
Clinical Study IdentifierTX135563
Last Modified on25 March 2021

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