Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ATI-5923
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Anticoagulation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- ARYx Investigational Site
- ARYx Investigational Site
- ARYx Investigational Site
- ARYx Investigational Site
- ARYx Investigational Site
- ARYx Investigational Site
- ARYx Investigational Site
- ARYx Investigational Site
- ARYx Investigational Site
- ARYx Investigational Site
- ARYx Investigational Site
Outcomes
Primary Outcome Measures
INR, Coagulation Factors II, VII, IX and X. Safety Measures: ECG, Laboratory and Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00431782
Brief Title
Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation
Official Title
An Open-Label Multi-Center Study of ATI-5923 for Anticoagulation in Patients With Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
ARYx Therapeutics
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Anticoagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ATI-5923
Primary Outcome Measure Information:
Title
INR, Coagulation Factors II, VII, IX and X. Safety Measures: ECG, Laboratory and Adverse Events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dave Ellis, M.D., Ph.D
Organizational Affiliation
ARYx Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
ARYx Investigational Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
ARYx Investigational Site
City
Yuba City
State/Province
California
Country
United States
Facility Name
ARYx Investigational Site
City
Deerfield Beach
State/Province
Florida
Country
United States
Facility Name
ARYx Investigational Site
City
Winfield
State/Province
Illinois
Country
United States
Facility Name
ARYx Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
ARYx Investigational Site
City
Wellsboro
State/Province
Pennsylvania
Country
United States
Facility Name
ARYx Investigational Site
City
Wynnewood
State/Province
Pennsylvania
Country
United States
Facility Name
ARYx Investigational Site
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
ARYx Investigational Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
ARYx Investigational Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
ARYx Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19738136
Citation
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.
Results Reference
derived
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Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation
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