Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00431782
Recruitment Status : Completed
First Posted : February 6, 2007
Last Update Posted : November 8, 2007
Information provided by:
ARYx Therapeutics

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: ATI-5923 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Multi-Center Study of ATI-5923 for Anticoagulation in Patients With Atrial Fibrillation
Study Start Date : December 2006
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. INR, Coagulation Factors II, VII, IX and X. Safety Measures: ECG, Laboratory and Adverse Events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00431782

United States, California
ARYx Investigational Site
Anaheim, California, United States
ARYx Investigational Site
Yuba City, California, United States
United States, Florida
ARYx Investigational Site
Deerfield Beach, Florida, United States
United States, Illinois
ARYx Investigational Site
Winfield, Illinois, United States
United States, Oklahoma
ARYx Investigational Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
ARYx Investigational Site
Wellsboro, Pennsylvania, United States
ARYx Investigational Site
Wynnewood, Pennsylvania, United States
United States, South Carolina
ARYx Investigational Site
Greer, South Carolina, United States
ARYx Investigational Site
Spartanburg, South Carolina, United States
United States, Tennessee
ARYx Investigational Site
Memphis, Tennessee, United States
United States, Texas
ARYx Investigational Site
San Antonio, Texas, United States
Sponsors and Collaborators
ARYx Therapeutics
Study Director: Dave Ellis, M.D., Ph.D ARYx Therapeutics

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00431782     History of Changes
Other Study ID Numbers: ATI-5923-CLN-504
First Posted: February 6, 2007    Key Record Dates
Last Update Posted: November 8, 2007
Last Verified: May 2007

Keywords provided by ARYx Therapeutics:
Atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes