Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title: An Open-Label Multi-Center Study of ATI-5923 for Anticoagulation in Patients With Atrial Fibrillation

Status Completed

Clinical Trial Summary

The primary purpose of this study (CLN-504) is to determine the safety and develop a dosing regimen of an investigational anticoagulant drug (ATI-5923) in patients with atrial fibrillation.

Clinical Trial Description

ATI-5923 is a structural analog of warfarin that is being developed as an oral anticoagulant. It has a similar pharmacological profile to warfarin but was designed to provide more uniform and stable anticoagulation. ATI-5923 is a selective, non-competitive inhibitor of vitamin K epoxide reductase. ATI-5923 is metabolized by esterase to a single inactive metabolite and thus is expected to have less variable metabolism, drug-drug interactions and reduced instances of under/over coagulation, making the response safer and more predictable. The primary purpose of this study is to develop a dosing regimen and INR monitoring schedule that can be applied in an outpatient setting to safely and conveniently anticoagulate patients with atrial fibrillation to a therapeutic INR. Patients with atrial fibrillation (AF) were chosen for the study population of this trial because they require anticoagulation if they have risk factors for stroke. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT00431782
• Study type: Interventional
• Source: ARYx Therapeutics
• Status: Completed
• Phase: Phase 2
• Start date: December 2006
• Completion date: October 2007