Warfarin Initiation in Mechanical Mitral Valve Replacement Patients

• Status: Completed
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

Summary

A prospective, comparative study evaluating warfarin initiation in a dose of 3mg versus 5mg in mechanical mitral valve prostheses patients who received anticoagulation with warfarin with the use of enoxaparen as a bridging agent .Fifty patients were included and compared in terms of the primary outcome time to reach therapeutic INR range.Other outcomes includes proportion of patients who achieved the target INR of 2.0-3.0 between day 3 and day 5, total dose of enoxaparin required for bridging, safety related to both doses of anticoagulants used

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sarah Sabry Hashem
• Treatments: Enoxaparin; Enoxaparin sodium; Warfarin

Criteria

Inclusion Criteria:

• New mechanical mitral valve prostheses patients who will receive anticoagulation with warfarin with the use of enoxaparen as a bridging agent.

Exclusion Criteria:

• Pregnant or lactating women

• Renal disorder (GFR = 45< mL/min) or patients on renal dialysis

• Hepatic disorder (Child Pugh class B or C)

• Clinically significant active bleeding.

• Recurrent DVT or PE.

• Baseline INR >1.2

• Asian ancestry

• Cancer

• Impaired nutritional status

• Alcohol abuse