Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation
An Open-Label Multi-Center Study of ATI-5923 for Anticoagulation in Patients With Atrial Fibrillation
1 other identifier
interventional
60
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 atrial-fibrillation
Started Dec 2006
Shorter than P25 for phase_2 atrial-fibrillation
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 2, 2007
CompletedFirst Posted
Study publicly available on registry
February 6, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedNovember 8, 2007
May 1, 2007
February 2, 2007
November 7, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
INR, Coagulation Factors II, VII, IX and X. Safety Measures: ECG, Laboratory and Adverse Events
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
ARYx Investigational Site
Anaheim, California, United States
ARYx Investigational Site
Yuba City, California, United States
ARYx Investigational Site
Deerfield Beach, Florida, United States
ARYx Investigational Site
Winfield, Illinois, United States
ARYx Investigational Site
Oklahoma City, Oklahoma, United States
ARYx Investigational Site
Wellsboro, Pennsylvania, United States
ARYx Investigational Site
Wynnewood, Pennsylvania, United States
ARYx Investigational Site
Greer, South Carolina, United States
ARYx Investigational Site
Spartanburg, South Carolina, United States
ARYx Investigational Site
Memphis, Tennessee, United States
ARYx Investigational Site
San Antonio, Texas, United States
Related Publications (1)
Ellis DJ, Usman MH, Milner PG, Canafax DM, Ezekowitz MD. The first evaluation of a novel vitamin K antagonist, tecarfarin (ATI-5923), in patients with atrial fibrillation. Circulation. 2009 Sep 22;120(12):1029-35, 2 p following 1035. doi: 10.1161/CIRCULATIONAHA.109.856120. Epub 2009 Sep 8.
PMID: 19738136DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dave Ellis, M.D., Ph.D
ARYx Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 2, 2007
First Posted
February 6, 2007
Study Start
December 1, 2006
Study Completion
October 1, 2007
Last Updated
November 8, 2007
Record last verified: 2007-05