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Completed

NCT Number: NCT04235569

Warfarin Initiation in Mechanical Mitral Valve Replacement Patients

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

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Key information

Conditions

Mitral Valve Disease

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Cardiovascular Hospital

Heliopolis, Cairo Governorate, 11355, Egypt

About this study

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Blood samples were withdrawn from patients for evaluation of INR.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Warfarin Sodium 5 MG

Drug

warfarin sodium 5mg tablets

Other names: Marevan 5mg

Warfarin Sodium 3 MG

Drug

warfarin sodium 3mg tablets

Other names: Marevan 3mg

Enoxaparin Sodium 100 MG/ML Prefilled Syringe

Drug

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 names: Clexane

Primary outcomes

  1. Efficacy of warfarin initiating dose and the corresponding dosing schedule: Time to reach therapeutic INR range (TTR)

    Time frame: 4-16 days

    Time to reach therapeutic INR range (TTR):The time in days required for the patient from the start of warfarin initiation till reaching the therapeutic

Secondary outcomes

  1. Evaluation of overanticoagulation

    Time frame: from 3 to 5 days

    Proportion of patients who achieved the target INR of 2.0-3.0 between day 3 and day 5

  2. Anticoagulation Safety evaluation

    Time frame: from 4 to 16 days

    Incidence of major and minor bleeding events

  3. Low Molecular Weight Heparin consumption

    Time frame: from 4 to 16 days

    The total dose of enoxaparin in mg that the patient received till discontinuation of bridging

  4. The Overall cost evaluation

    Time frame: from 4 to 16 days

    total cost spent in LE during the follow up period calculated by the summation of the cost of treatment , cost of bleeding event management and cost of hospital stay.

Sponsors and collaborators

Lead sponsor

Sarah Sabry Hashem

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 22, 2020
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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