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Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation

This study has been completed.
Information provided by:
ARYx Therapeutics Identifier:
First received: February 2, 2007
Last updated: November 7, 2007
Last verified: May 2007
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 Intervention Phase
Atrial Fibrillation
Drug: ATI-5923
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Multi-Center Study of ATI-5923 for Anticoagulation in Patients With Atrial Fibrillation

Resource links provided by NLM:

Further study details as provided by ARYx Therapeutics:

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

Estimated Enrollment: 60
Study Start Date: December 2006
Study Completion Date: October 2007
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.

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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00431782     History of Changes
Other Study ID Numbers: ATI-5923-CLN-504
Study First Received: February 2, 2007
Last Updated: November 7, 2007

Keywords provided by ARYx Therapeutics:
Atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on April 27, 2017