Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation

Phase 2

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT00431782
• Lead Sponsor: ARYx Therapeutics

Brief 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.

Detailed 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 Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-02-02
• Study First Submitted QC: 2007-02-02
• Study First Posted: 2007-02-06
• Status Verified: 2007-05
• Study Completion: 2007-10
• Last Update Submitted: 2007-11-07
• Last Update Posted: 2007-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Documented atrial fibrillation
• Candidate for anticoagulation or currently receiving warfarin at screening
• Males or females greater than 18 years of age
• Males or females with a CHADS2 score of 0 to 2

Exclusion Criteria

• Contraindications to anticoagulation e.g., active bleeding
• Taking other anticoagulant or antiplatelet agents other than low-dose aspirin
• History of myocardial infarction, acute coronary syndrome, or coronary revascularization procedure within the past 3 months prior to Day 1
• History of laboratory values suggestive of anemia (i.e., Hb <10 gm/dL)
• Women of childbearing potential

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
INR, Coagulation Factors II, VII, IX and X. Safety Measures: ECG, Laboratory and Adverse Events

Trial Locations

Locations (1)

ARYx Investigational Site; 🇺🇸 San Antonio, Texas, United States