Safety And Efficacy of Low Dose Oral Anticoagulants And Aspirin Therapy

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yasser Elnahas
• Treatments: Anticoagulants; Aspirin; Phenindione; Warfarin

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.