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Warfarin Initiation in Mechanical Mitral Valve Replacement Patients

NCT04235569 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-01-27

No results posted yet for this study

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

Conditions

  • Mitral Valve Disease

Interventions

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.

Sponsors & Collaborators

  • Sarah Sabry Hashem

    lead OTHER

Principal Investigators

  • Ayman M Saleh, MD · Ain Shams University

  • Lamiaa M ElWakeel, PhD · Faculty of pharmacy Ain Shams University

  • Marwa A Ahmed, PhD · Faculty of pharmacy Ain Shams University

  • Sarah S Hashem, Msc · The Cardiovascular Hospital Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-01-01
Completion
2019-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04235569 on ClinicalTrials.gov