NCT01758640

Brief Summary

A prospective, randomized, longitudinal, open label, parallel group clinical trial was designed to compare the proportions of failure to reach INR target 2.5-3.5 with either: small dose warfarin (\<5 mg/day) or phenindione (\<100 mg/day), in high-risk pregnant and non-pregnant patients with bileaflet mechanical heart valve prosthesis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2010

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

February 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

2.3 years

First QC Date

December 25, 2012

Last Update Submit

January 25, 2013

Conditions

Anticoagulation in Pregnancy

Keywords

mechanical heart valvepregnancywarfarinphenindione

Outcome Measures

Primary Outcomes (1)

  • proportions of failure to reach target INR (2.5-3.5) with a maximum daily dose of 5mg warfarin or 100 mg phenindione

    Low dose warfarin is recommended for pregnant patients with mechanical heart valves to avoid drug related congenital anomalies. The aim of our study is to question if this low dose can achieve target INR in high risk patients with mechanical heart valves implanted in mitral +/- aortic position.

    9 Months

Secondary Outcomes (4)

  • Proportions of adverse patients (maternal) outcomes

    9 Months

  • Proportions of adverse fetal outcomes

    9 months

  • INR achieved with a maximum dose of 5mg warfarin or 100 mg phenindione

    9 months

  • Daily dose of oral anticoagulant in pregnant and non pregnant patients

    9 Months

Study Arms (2)

Pregnant

ACTIVE COMPARATOR

Group of Pregnant patients who will receive either warfarin or phenindione according to the study design

Drug: WarfarinDrug: phenindione

Non Pregnant

ACTIVE COMPARATOR

Group Of Non Pregnant patients who will receive either warfarin or phenindione according to the study design

Drug: WarfarinDrug: phenindione

Interventions

WarfarinDRUG

Low dose warfarin of 5mg or less per day

Non PregnantPregnant
phenindioneDRUG

Phenindione of 100mg or less per day

Non PregnantPregnant

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Regular menstrual cycles and no history of congenital malformation, repeated abortions or still birth.
  • Patients in NYHA class I or II c) regular INR records for the last 3 months, with the target INR being achieved with warfarin not exceeding 10 mg/day.
  • Patient accepting to participate in the study
  • Getting pregnant for Group A patients

You may not qualify if:

  • Patients were excluded from either groups if they refuse to participate in the study or to sign the informed consent.
  • Pregnant patients were excluded from Group A if reporting their missed menstrual period or positive pregnancy test later than the 6th week of gestation.
  • Patients were excluded from Group B whenever they get pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams University Hospitals

Cairo, Egypt

Location

Related Publications (1)

  • Hassouna A, Allam H. Oral anticoagulation therapy during pregnancy in patients with mechanical mitral valves: a prospective study. Cardiovasc Surg. 2001 Oct;9(5):478-81. doi: 10.1016/s0967-2109(01)00020-5.

    PMID: 11489653BACKGROUND

MeSH Terms

Interventions

WarfarinPhenindione

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Ahmed A Hassouna, M.D

    Ain Shams University, Cairo Egypr

    STUDY DIRECTOR

  • Yasser M Elnahas, M.D.

    Ain Shams University

    PRINCIPAL INVESTIGATOR

  • Ahmed M Toema, M.SC.

    Ain Shams University

    PRINCIPAL INVESTIGATOR

  • ayman Ammar, M.D

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

December 25, 2012

First Posted

January 1, 2013

Study Start

February 1, 2010

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

EG(1)