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Sponsored by: |
ARYx Therapeutics |
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Information provided by: | ARYx Therapeutics |
ClinicalTrials.gov Identifier: | NCT00691470 |
The purpose of this research study is to test an experimental drug ATI-5923 vs Coumadin. The study is intended to demonstrate ATI-5923 is superior to Coumadin for keeping INR values in the desired therapeutic range. Patients who require chronic anticoagulation with one or more of the following conditions are eligible for the study: atrial fibrillation or atrial flutter, prosthetic heart valve, venous thromboembolic disease, or history of myocardial infarction or cardiomyopathy will be enrolled.
Condition | Intervention | Phase |
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Atrial Fibrillation Atrial Flutter Venous Thromboembolic Disease Myocardial Infarction Cardiomyopathy |
Drug: ATI-5923 Drug: Coumadin (warfarin) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double Blind Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation |
Estimated Enrollment: | 600 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1. ATI-5923: Experimental
Dose adjusted ATI-5923
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Drug: ATI-5923
Dose Adjusted based on INR.
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2. Coumadin: Active Comparator
Dose adjusted Coumadin (warfarin)
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Drug: Coumadin (warfarin)
Dose adjusted based on INR.
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The primary study objective is to evaluate whether ATI-5923 is superior to adjusted dose warfarin in the quality of anticoagulation as measured by interpolated INR time in therapeutic range. This is a Phase II/III multi-center, randomized, stratified, double blind, parallel group, active control study comparing ATI-5923 with Coumadin in patients who require chronic, oral anticoagulation. Up to 600 patients who successfully complete all screening assessments and meet all eligibility criteria will be enrolled in the study and receive study drug treatment for 6-12 months depending on time of study entry.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with one or more of the following indications for chronic warfarin anticoagulation (the patient may either be a new candidate for anticoagulation or may already be receiving warfarin):
Exclusion Criteria:
Responsible Party: | ARYx Therapeutics, Inc ( Daniel Canafax ) |
Study ID Numbers: | CLN-505 |
Study First Received: | June 3, 2008 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00691470 |
Health Authority: | United States: Food and Drug Administration |
Anticoagulation Vitamin K-dependent clotting factor inhibitor Coumadin Warfarin Atrial fibrillation Prosthetic heart valve Venous thromboembolic disease |
Myocardial infarction or cardiomyopathy Patients with one or more of the following indications for chronic warfarin anticoagulation: Atrial fibrillation (paroxysmal, persistent or permanent, not due to a reversible cause, documented by ECG) or atrial flutter; A prosthetic heart valve in the aortic or mitral position that requires chronic anticoagulation; A history of venous thromboembolic disease (DVT and/or PE) requiring long term anticoagulation (> 6 months); A history of myocardial infarction or cardiomyopathy requiring anticoagulation. Currently receiving chronic warfarin therapy for another indication not listed, with Sponsor approval. |
Heart Diseases Myocardial Ischemia Vascular Diseases Warfarin Ischemia Cardiomyopathies Thromboembolism Atrial Flutter Thrombosis |
Antiplasmin Embolism and Thrombosis Necrosis Embolism Vitamin K Atrial Fibrillation Infarction Myocardial Infarction Arrhythmias, Cardiac |
Anticoagulants Molecular Mechanisms of Pharmacological Action Coagulants Growth Substances Physiological Effects of Drugs Hematologic Agents Pharmacologic Actions Hemostatics |
Fibrin Modulating Agents Pathologic Processes Antifibrinolytic Agents Therapeutic Uses Vitamins Cardiovascular Diseases Micronutrients |