Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ARYx Investigational Site
🇺🇸San Antonio, Texas, United States
ARYx Investigational Site🇺🇸San Antonio, Texas, United States