NCT04235569

Warfarin Initiation in Mechanical Mitral Valve Replacement Patients

Evaluation of Warfarin Initiation at 3mg Versus 5mg for Anticoagulation of Mechanical Mitral Valve Replacement Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Sarah Sabry Hashem · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 Blood samples were withdrawn from patients for evaluation of INR.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.

Conditions

• Mitral Valve Disease

Interventions

Type	Name	Description
DRUG	Warfarin Sodium 5 MG	warfarin sodium 5mg tablets
DRUG	Warfarin Sodium 3 MG	warfarin sodium 3mg tablets
DRUG	Enoxaparin Sodium 100 MG/ML Prefilled Syringe	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.

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-01-01
• Completion: 2019-09-01
• First posted: 2020-01-22
• Last updated: 2020-01-27

Locations

1 site across 1 country: Egypt