A Double Blind Randomized Control Trial of Post-Operative Low Molecular Weight Heparin Bridging Therapy Versus Placebo Bridging Therapy for Patients Who Are at High Risk for Arterial Thromboembolism (PERIOP 2)

NCT00432796 Phase 3 UNKNOWN

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.

Details

Lead sponsor	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Phase	Phase 3
Status	UNKNOWN
Enrolment	1473
Start date	2006-12
Completion	2020-12

Conditions

• Stroke

Interventions

• Dalteparin
• Placebo

Primary outcomes

• major thromboembolism — 90 days from randomization

Countries

Canada, India