Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation (EmbraceAC)
Recruitment status was Active, not recruiting
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.
Venous Thromboembolic Disease
Drug: Coumadin (warfarin)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double Blind Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation|
- Percent of time INR is in therapeutic range after the exclusion of the first 4 weeks of treatment, using the linear interpolation method of Rosendaal(Rosendaal, 1993). [ Time Frame: After the first month through end of study. ] [ Designated as safety issue: Yes ]
- The proportion of all study recorded INR values that are within the target range, after the exclusion of the INR values from the first 4 weeks of treatment [ Time Frame: After the first month through end of study ] [ Designated as safety issue: Yes ]
- Proportion of time patients have significant deviations from therapeutic INR range. [ Time Frame: After the first month through end of study ] [ Designated as safety issue: Yes ]
- A composite of the following clinically important outcome events [ Time Frame: After the first month through end of study ] [ Designated as safety issue: Yes ]
|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)|
Experimental: 1. ATI-5923
Dose adjusted ATI-5923
Dose Adjusted based on INR.
Active Comparator: 2. Coumadin
Dose adjusted Coumadin (warfarin)
Drug: Coumadin (warfarin)
Dose adjusted based on INR.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691470
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