Safety And Efficacy of Low Dose Oral Anticoagulants And Aspirin Therapy

Phase 3 Completed 200 enrolled Yasser Elnahas

RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start: 2010-02
Primary completion: 2012-06
Completion: 2012-08

Publications

Background 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: 10.1177/096721090100900512.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Phenindione	Small molecule	100 mg	—
Comparator	Warfarin	Small molecule	5 mg	—

Indications

No indication recorded.