Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation (EmbraceAC)
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|ClinicalTrials.gov Identifier: NCT00691470|
Recruitment Status : Unknown
Verified October 2008 by ARYx Therapeutics.
Recruitment status was: Active, not recruiting
First Posted : June 5, 2008
Last Update Posted : February 2, 2010
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Atrial Flutter Venous Thromboembolic Disease Myocardial Infarction Cardiomyopathy||Drug: ATI-5923 Drug: Coumadin (warfarin)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double Blind Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||June 2009|
|Estimated Study Completion Date :||June 2009|
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.
- 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. ]
- 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 ]
- Proportion of time patients have significant deviations from therapeutic INR range. [ Time Frame: After the first month through end of study ]
- A composite of the following clinically important outcome events [ Time Frame: After the first month through end of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691470