Warfarin Initiation in Mechanical Mitral Valve Replacement Patients
Condition: Mitral Valve Disease
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      Inpatients of The Cardiovascular hospital who had undergone mitral heart valve replacement
      with a mechanical prosthesis and commencing warfarin were eligible for inclusion. Patients
      were included after they had newly undergone elective surgery for implantation of mechanical
      mitral heart valves, had commenced on warfarin, received enoxaparin as a bridging agent and
      had INR monitored for a minimum of 4 consecutive days after warfarin initiation.

      A total of 50 consecutive MVR patients were recruited. Each was assigned to either the group
      I (25 patients) or the group II (25 patients) group. All patients received the conventional
      postoperative treatment including: Diuretics, beta-blockers, digoxin or heart rate-regulating
      calcium channel blockers and anticoagulation bridging therapy using LMWH according to the
      European Society of Cardiology (ESC) Guidelines for the management of MVR and antibiotic for
      48hour after surgery according to the investigator's hospital's antibiotic protocol.

      Baseline evaluation included demographics and history taking. After obtaining the informed
      consent, information including age, weight, height, smoking state, and other diseases e.g.
      hypertension, diabetes, hyperlipidemias, etc. were documented for each patient. Medication
      history in details, as well as the background cardiovascular treatment was considered.

      Blood samples were withdrawn from patients for evaluation of INR. Complete blood count,
      kidney and liver function tests were performed as part of the routine admission care.

      All patients were followed up daily post operative till reaching an in range INR value. All
      patients were observed daily for INR values and dose adjusted accordingly and also estimation
      of incidence and severity of bleeding complications was done.
    

Intervention name(s): Warfarin Sodium 5 MG; Warfarin Sodium 3 MG; Enoxaparin Sodium 100 MG/ML Prefilled Syringe
Intervention type(s): Drug; Drug; Drug
Intervention description(s): warfarin sodium 5mg tablets; warfarin sodium 3mg tablets; Clexane® Syringes 2,000 IU (20 mg)/0.2 ml solution for injection in pre-filled syringes.
Clexane® Syringes 4,000 IU (40 mg)/0.4 ml solution for injection in pre-filled syringes.
Clexane® Syringes 6,000 IU (60 mg)/0.6 ml solution for injection in pre-filled syringes.
Clexane® Syringes 8,000 IU (80 mg)/0.8 ml solution for injection in pre-filled syringes.
Dose was determined individually for each patient as 1mg/kg every 12 hours.
Other intervention name(s): Marevan 5mg; Marevan 3mg; Clexane
Intervention MeSH terms: Enoxaparin; Warfarin; Enoxaparin sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: warfarin; anticoagulation; mitral valve replacement