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Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation

NCT ID: NCT00431782

Last Updated: 2007-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrial Fibrillation

Keywords

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Atrial fibrillation Anticoagulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ATI-5923

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ARYx Therapeutics

INDUSTRY

Sponsor Role lead

Principal Investigators

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Dave Ellis, M.D., Ph.D

Role: STUDY_DIRECTOR

ARYx Therapeutics

Locations

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ARYx Investigational Site

Anaheim, California, United States

Site Status

ARYx Investigational Site

Yuba City, California, United States

Site Status

ARYx Investigational Site

Deerfield Beach, Florida, United States

Site Status

ARYx Investigational Site

Winfield, Illinois, United States

Site Status

ARYx Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

ARYx Investigational Site

Wellsboro, Pennsylvania, United States

Site Status

ARYx Investigational Site

Wynnewood, Pennsylvania, United States

Site Status

ARYx Investigational Site

Greer, South Carolina, United States

Site Status

ARYx Investigational Site

Spartanburg, South Carolina, United States

Site Status

ARYx Investigational Site

Memphis, Tennessee, United States

Site Status

ARYx Investigational Site

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Ellis DJ, Usman MH, Milner PG, Canafax DM, Ezekowitz MD. The first evaluation of a novel vitamin K antagonist, tecarfarin (ATI-5923), in patients with atrial fibrillation. Circulation. 2009 Sep 22;120(12):1029-35, 2 p following 1035. doi: 10.1161/CIRCULATIONAHA.109.856120. Epub 2009 Sep 8.

Reference Type DERIVED
PMID: 19738136 (View on PubMed)

Other Identifiers

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ATI-5923-CLN-504

Identifier Type: -

Identifier Source: org_study_id