NCT04235569

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

January 15, 2020

Last Update Submit

January 23, 2020

Conditions

Mitral Valve Disease

Keywords

warfarinanticoagulationmitral valve replacement

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (4)

  • Evaluation of overanticoagulation

    from 3 to 5 days

  • Anticoagulation Safety evaluation

    from 4 to 16 days

  • Low Molecular Weight Heparin consumption

    from 4 to 16 days

  • The Overall cost evaluation

    from 4 to 16 days

Study Arms (2)

Group I

EXPERIMENTAL

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 MGDrug: Enoxaparin Sodium 100 MG/ML Prefilled Syringe

Group II

EXPERIMENTAL

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: Warfarin Sodium 3 MGDrug: Enoxaparin Sodium 100 MG/ML Prefilled Syringe

Interventions

Warfarin Sodium 5 MGDRUG

warfarin sodium 5mg tablets

Also known as: Marevan 5mg
Group I
Warfarin Sodium 3 MGDRUG

warfarin sodium 3mg tablets

Also known as: Marevan 3mg
Group II
Enoxaparin Sodium 100 MG/ML Prefilled SyringeDRUG

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.

Also known as: Clexane
Group IGroup II

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • New mechanical mitral valve prostheses patients who will receive anticoagulation with warfarin with the use of enoxaparen as a bridging agent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cardiovascular Hospital

Heliopolis, Cairo Governorate, 11355, Egypt

Location

Related Publications (8)

  • Suwanawiboon B, Kongtim P, Chinthammitr Y, Ruchutrakool T, Wanachiwanawin W. The efficacy of 3-mg warfarin initiating dose in adult Thai patients, who required long-term anticoagulant therapy. J Med Assoc Thai. 2011 Feb;94 Suppl 1:S225-31.

    PMID: 21721451BACKGROUND

  • Roberts G, Razooqi R, Quinn S. Comparing Usual Care With a Warfarin Initiation Protocol After Mechanical Heart Valve Replacement. Ann Pharmacother. 2017 Mar;51(3):219-225. doi: 10.1177/1060028016676830. Epub 2016 Oct 26.

    PMID: 27798318BACKGROUND

  • Dong L, Shi YK, Xu JP, Zhang EY, Liu JC, Li YX, Ni YM, Yang Q, Han T, Fu B, Chen J, Ren L, Wei SL, Chen H, Liu KX, Yu FX, Liu JS, Xiao MD, Wu SM, Zhang KL, Huang HL, Jiang SL, Qiao CH, Wang CS, Xu ZY, Zhou XM, Wang DJ, Ni LX, Xiao YB, Jiang SL, Zhang GM, Liang GY, Yang SY, Bo P, Zhong QJ, Zhang JB, Zhang X, Zhu YB, Teng X, Zhu P, Huang F, Xiao YM, Cao GQ, Tian H, Xia LM, Lu FL, Liu YQ, Liu DX, Xu H, Yuan Y, Li M, Chang C, Wu XC, Xu Z, Guo P, Bai YJ, Xue WB, Jiang XY, Na ZH, Zeng QY, Cai H, Wang YL, Xiong R, Jin S, Zheng XM, Wu D. [The multicenter study on the registration and follow-up of low anticoagulation therapy for the heart valve operation in China]. Zhonghua Yi Xue Za Zhi. 2016 May 24;96(19):1489-94. doi: 10.3760/cma.j.issn.0376-2491.2016.19.006. Chinese.

    PMID: 27266493BACKGROUND

  • Bayliss A, Faber P, Dunning J, Ronald A. What is the optimal level of anticoagulation in adult patients receiving warfarin following implantation of a mechanical prosthetic mitral valve? Interact Cardiovasc Thorac Surg. 2007 Jun;6(3):390-6. doi: 10.1510/icvts.2007.152819. Epub 2007 Feb 9.

    PMID: 17669876BACKGROUND

  • Yoon IK, Lee KE, Lee JK, Chang BC, Gwak HS. Adequate intensity of warfarin therapy for Korean patients with mechanical cardiac valves. J Heart Valve Dis. 2013 Jan;22(1):102-9.

    PMID: 23610997BACKGROUND

  • Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Jul 11;70(2):252-289. doi: 10.1016/j.jacc.2017.03.011. Epub 2017 Mar 15. No abstract available.

    PMID: 28315732BACKGROUND

  • Mahtani KR, Heneghan CJ, Nunan D, Bankhead C, Keeling D, Ward AM, Harrison SE, Roberts NW, Hobbs FD, Perera R. Optimal loading dose of warfarin for the initiation of oral anticoagulation. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD008685. doi: 10.1002/14651858.CD008685.pub2.

    PMID: 23235665BACKGROUND

  • Sabry S, El Wakeel LM, Saleh A, Ahmed MA. Comparison of Warfarin Initiation at 3 mg Versus 5 mg for Anticoagulation of Patients with Mechanical Mitral Valve Replacement Surgery: A Prospective Randomized Trial. Clin Drug Investig. 2022 Apr;42(4):309-318. doi: 10.1007/s40261-022-01137-7. Epub 2022 Mar 10.

    PMID: 35274222DERIVED

MeSH Terms

Interventions

Warfarinenoxaparin sodiumEnoxaparin

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Ayman M Saleh, MD

    Ain Shams University

    STUDY DIRECTOR

  • Lamiaa M ElWakeel, PhD

    Faculty of pharmacy Ain Shams University

    STUDY DIRECTOR

  • Marwa A Ahmed, PhD

    Faculty of pharmacy Ain Shams University

    STUDY DIRECTOR

  • Sarah S Hashem, Msc

    The Cardiovascular Hospital Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Msc, Clinical Pharmacy

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 22, 2020

Study Start

March 1, 2018

Primary Completion

January 1, 2019

Study Completion

September 1, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)