Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by:
ARYx Therapeutics
ClinicalTrials.gov Identifier:
NCT00431782
First received: February 2, 2007
Last updated: November 7, 2007
Last verified: May 2007
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431782

Locations
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
Investigators
Study Director: Dave Ellis, M.D., Ph.D ARYx Therapeutics
  More Information

No publications provided by ARYx Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00431782     History of Changes
Other Study ID Numbers: ATI-5923-CLN-504
Study First Received: February 2, 2007
Last Updated: November 7, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by ARYx Therapeutics:
Atrial fibrillation
Anticoagulation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014