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Safety And Efficacy of Low Dose Oral Anticoagulants And Aspirin Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yasser Elnahas, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01758640
First received: December 25, 2012
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Anticoagulation in Pregnancy
Drug: Warfarin
Drug: phenindione
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety And Efficacy of Low Dose Oral Anticoagulants And Aspirin Therapy Throughout Pregnancy In Patients With Mechanical Heart Valves Prosthesis

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • proportions of failure to reach target INR (2.5-3.5) with a maximum daily dose of 5mg warfarin or 100 mg phenindione [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Proportions of adverse patients (maternal) outcomes [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
    Maternal mortality and anticoagulant related bleeding and thromboembolic events

  • Proportions of adverse fetal outcomes [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Proportions of spontaneous abortions, fetal congenital malformations, prematurity, sill birth, neonatal death and total feta wastage.

  • INR achieved with a maximum dose of 5mg warfarin or 100 mg phenindione [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Daily dose of oral anticoagulant in pregnant and non pregnant patients [ Time Frame: 9 Months ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: February 2010
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pregnant
Group of Pregnant patients who will receive either warfarin or phenindione according to the study design
Drug: Warfarin
Low dose warfarin of 5mg or less per day
Drug: phenindione
Phenindione of 100mg or less per day
Active Comparator: Non Pregnant
Group Of Non Pregnant patients who will receive either warfarin or phenindione according to the study design
Drug: Warfarin
Low dose warfarin of 5mg or less per day
Drug: phenindione
Phenindione of 100mg or less per day

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758640

Locations
Egypt
Ain shams University Hospitals
Cairo, Egypt
Sponsors and Collaborators
Yasser Elnahas
Investigators
Study Director: Ahmed A Hassouna, M.D Ain Shams University, Cairo Egypr
Principal Investigator: 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
  More Information

Publications:
Responsible Party: Yasser Elnahas, M.D, Ain Shams University
ClinicalTrials.gov Identifier: NCT01758640     History of Changes
Other Study ID Numbers: AINSHAMS2012
Study First Received: December 25, 2012
Last Updated: January 25, 2013
Health Authority: Egypt: Ministry of Higher Education

Keywords provided by Ain Shams University:
mechanical heart valve
pregnancy
warfarin
phenindione

Additional relevant MeSH terms:
Anticoagulants
Phenindione
Warfarin
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014