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Safety And Efficacy of Low Dose Oral Anticoagulants And Aspirin Therapy

NCT01758640 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-01-28

No results posted yet for this study

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.

Conditions

  • Anticoagulation in Pregnancy

Interventions

DRUG

Warfarin

Low dose warfarin of 5mg or less per day

DRUG

phenindione

Phenindione of 100mg or less per day

Sponsors & Collaborators

  • Yasser Elnahas

    lead OTHER

Principal Investigators

  • Ahmed A Hassouna, M.D · Ain Shams University, Cairo Egypr

  • Yasser M Elnahas, M.D. · Ain Shams University

  • Ahmed M Toema, M.SC. · Ain Shams University

  • ayman Ammar, M.D · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-06-30
Completion
2012-08-31

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 NCT01758640 on ClinicalTrials.gov