Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation

November 7, 2007 updated by: ARYx Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARYx Therapeutics

Investigators

  • Study Director: Dave Ellis, M.D., Ph.D, ARYx Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 2, 2007

First Submitted That Met QC Criteria

February 2, 2007

First Posted (Estimate)

February 6, 2007

Study Record Updates

Last Update Posted (Estimate)

November 8, 2007

Last Update Submitted That Met QC Criteria

November 7, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATI-5923-CLN-504

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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