PERIOP 2 - A Safety and Effectiveness of LMWH vs Placebo Bridging Therapy for Patients on Long Term Warfarin Requiring Temporary Interruption of Warfarin.

• Status: Active, not recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine the effectiveness and safety of LMWH postoperative bridging therapy (standard of care) versus postoperative placebo bridging therapy (experimental arm)for patients with mechanical heart valves or atrial fibrillation or atrial flutter who are at high risk for stroke when warfarin is temporarily interrupted for a procedure.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); Pfizer
• Treatments: Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Warfarin

Criteria

Inclusion Criteria:

1. Informed consent,

2. Patients aged >18

3. Patients with prosthetic(mechanical) heart valve

4. Patients with atrial fibrillation or atrial flutter and a major risk factor (previous TIA or stroke, high blood pressure, diabetes, aged >75, moderate/severe left ventricle dysfunction)

5. Who are receiving long-term oral anticoagulation and require elective non-cardiac surgery or an invasive procedure with reversal of their anticoagulant therapy.

Exclusion Criteria:

1. Evidence of active bleeding within last 30 days prior to stopping warfarin.

2. Platelet count <100 x 109/L.

3. Spinal or neurosurgery.

4. Life expectancy less than 3 months.

5. Calculated creatinine clearance <30 ml/min

6. Patients requiring cardiac surgery.

7. Multiple prosthetic(mechanical) valves or Starr-Edwards valve or prosthetic(mechanical) valve with a history of stroke or TIA

8. History of heparin induced thrombocytopenia (HIT)