Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00431782

Enrollment

Registered

2007-02-06

Start date

2006-12-31

Completion date

2007-10-31

Last updated

2007-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Anticoagulation

Brief 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.

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.

Interventions

DRUGATI-5923

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026