Clinical trial NCT00431782: Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation
Official title: An Open-Label Multi-Center Study of ATI-5923 for Anticoagulation in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Anticoagulation
Lead sponsor: ARYx Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: INR, Coagulation Factors II, VII, IX and X. Safety Measures: ECG, Laboratory and Adverse Events
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: ARYx Investigational Site
state: California
city: Yuba City
country: United States
facility: ARYx Investigational Site
state: California
city: Deerfield Beach
country: United States
facility: ARYx Investigational Site
state: Florida
city: Winfield
country: United States
facility: ARYx Investigational Site
state: Illinois
city: Oklahoma City
country: United States
facility: ARYx Investigational Site
state: Oklahoma
city: Wellsboro
country: United States
facility: ARYx Investigational Site
state: Pennsylvania
city: Wynnewood
country: United States
facility: ARYx Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: ARYx Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: ARYx Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: ARYx Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: ARYx Investigational Site
state: Texas
Study officials:
affiliation: ARYx Therapeutics
name: Dave Ellis, M.D., Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.