Warfarin Initiation in Mechanical Mitral Valve Replacement Patients

January 23, 2020 updated by: Sarah Sabry Hashem

Evaluation of Warfarin Initiation at 3mg Versus 5mg for Anticoagulation of 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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Blood samples were withdrawn from patients for evaluation of INR.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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo
      • Heliopolis, Cairo, Egypt, 11355
        • The Cardiovascular Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I

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.
Drug: Warfarin Sodium 5 MG
warfarin sodium 5mg tablets
Other Names:
  • Marevan 5mg
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.

Other Names:
  • Clexane
Experimental: Group II

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.
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.

Other Names:
  • Clexane
Drug: Warfarin Sodium 3 MG
warfarin sodium 3mg tablets
Other Names:
  • Marevan 3mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4-16 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from 3 to 5 days
Anticoagulation Safety evaluation
Time Frame: from 4 to 16 days
Incidence of major and minor bleeding events
from 4 to 16 days
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
from 4 to 16 days
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.
from 4 to 16 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sarah Sabry Hashem

Investigators

  • Study Director: Ayman M Saleh, MD, Ain Shams University Hospitals
  • Study Director: Lamiaa M ElWakeel, PhD, faculty of pharmacy Ain Shams university
  • Study Director: Marwa A Ahmed, PhD, faculty of pharmacy Ain Shams university
  • Principal Investigator: Sarah S Hashem, Msc, The Cardiovascular Hospital Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 16, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11222 (Registry Identifier: DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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