Warfarin Initiation in Mechanical Mitral Valve Replacement Patients

Sarah Sabry Hashem

Status and phase: Completed; Phase 4

Conditions: Mitral Valve Disease

Treatments: Drug: Warfarin Sodium 5 MG; Drug: Enoxaparin Sodium 100 MG/ML Prefilled Syringe; Drug: Warfarin Sodium 3 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04235569

11222 (Registry Identifier)

Details and patient eligibility

About

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

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Blood samples were withdrawn from patients for evaluation of INR.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

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

Group I

Experimental group

Description:

a group of 25 patients received 5mg Marevan ® tablets as initiation warfarin dose in combination of enoxaparin (Clexane® ) as a bridging agent.INR was monitored daily and dose adjustments were done to reach therapeutic INR range (2-3) at which the Enoxaparen was discontinued.Follow up was continued till first INR reading in therapeutic range. Bleeding events due to overanticoagulation were monitored through the follow up period.

Treatment:

Drug: Enoxaparin Sodium 100 MG/ML Prefilled Syringe

Drug: Warfarin Sodium 5 MG

Group II

Experimental group

Description:

a group of 25 patients received 3mg Marevan ® tablets as initiation warfarin dose in combination of enoxaparin (Clexane® ) as a bridging agent.INR was monitored daily and dose adjustments were done to reach therapeutic INR range (2-3) at which the Enoxaparen was discontinued.Follow up was continued till first INR reading in therapeutic range. Bleeding events due to overanticoagulation were monitored through the follow up period.

Treatment:

Drug: Warfarin Sodium 3 MG

Drug: Enoxaparin Sodium 100 MG/ML Prefilled Syringe