Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

An Open-Label Multi-Center Study of ATI-5923 for Anticoagulation in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00431782
• Other study ID #: ATI-5923-CLN-504
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2007
• Last updated: November 7, 2007
• Start date: December 2006
• Est. completion date: October 2007

Study information

• Verified date: May 2007
• Source: ARYx Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• ATI-5923

Locations

Country	Name	City	State
United States	ARYx Investigational Site	Anaheim	California
United States	ARYx Investigational Site	Deerfield Beach	Florida
United States	ARYx Investigational Site	Greer	South Carolina
United States	ARYx Investigational Site	Memphis	Tennessee
United States	ARYx Investigational Site	Oklahoma City	Oklahoma
United States	ARYx Investigational Site	San Antonio	Texas
United States	ARYx Investigational Site	Spartanburg	South Carolina
United States	ARYx Investigational Site	Wellsboro	Pennsylvania
United States	ARYx Investigational Site	Winfield	Illinois
United States	ARYx Investigational Site	Wynnewood	Pennsylvania
United States	ARYx Investigational Site	Yuba City	California

Sponsors (1)

Lead Sponsor	Collaborator
ARYx Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	INR, Coagulation Factors II, VII, IX and X. Safety Measures: ECG, Laboratory and Adverse Events