Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation

NCT ID: NCT00691470

Last Updated: 2010-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-06-30

Brief Summary

The purpose of this research study is to test an experimental drug ATI-5923 vs Coumadin. The study is intended to demonstrate ATI-5923 is superior to Coumadin for keeping INR values in the desired therapeutic range. Patients who require chronic anticoagulation with one or more of the following conditions are eligible for the study: atrial fibrillation or atrial flutter, prosthetic heart valve, venous thromboembolic disease, or history of myocardial infarction or cardiomyopathy will be enrolled.

Detailed Description

The primary study objective is to evaluate whether ATI-5923 is superior to adjusted dose warfarin in the quality of anticoagulation as measured by interpolated INR time in therapeutic range. This is a Phase II/III multi-center, randomized, stratified, double blind, parallel group, active control study comparing ATI-5923 with Coumadin in patients who require chronic, oral anticoagulation. Up to 600 patients who successfully complete all screening assessments and meet all eligibility criteria will be enrolled in the study and receive study drug treatment for 6-12 months depending on time of study entry.

Conditions

Atrial Fibrillation; Atrial Flutter; Venous Thromboembolic Disease; Myocardial Infarction; Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1. ATI-5923

Dose adjusted ATI-5923

Group Type: EXPERIMENTAL

ATI-5923

Intervention Type: DRUG

Dose Adjusted based on INR.

2. Coumadin

Dose adjusted Coumadin (warfarin)

Group Type: ACTIVE_COMPARATOR

Coumadin (warfarin)

Intervention Type: DRUG

Dose adjusted based on INR.

Interventions

ATI-5923

Dose Adjusted based on INR.

Intervention Type: DRUG

Coumadin (warfarin)

Dose adjusted based on INR.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with one or more of the following indications for chronic warfarin anticoagulation (the patient may either be a new candidate for anticoagulation or may already be receiving warfarin):

1. Atrial fibrillation (paroxysmal, persistent or permanent, not due to a reversible cause, documented by ECG) or atrial flutter.

2. A prosthetic heart valve in the aortic or mitral position that requires chronic anticoagulation.

3. A history of venous thromboembolic disease (DVT and/or PE) requiring long term anticoagulation (> 6 months).

4. A history of myocardial infarction or cardiomyopathy requiring anticoagulation.

5. Currently receiving chronic warfarin therapy for another indication not listed, with Sponsor approval.

2. Male or female greater than 18 years of age.

3. Able and willing to sign IRB approved written informed consent to participate in the study.

4. Able and willing to follow instructions, to comply with protocol requirements, and to attend required study visits.

Exclusion Criteria

1. Contraindications to anticoagulation as listed in the warfarin package insert (Appendix D), such as active bleeding or lesions at risk of bleeding such as gastric ulceration, colonic or cerebral AV malformations, cerebral or aortic aneurysms, pericarditis or endocarditis. Patients who have had recent (< 14 days from screening) surgery or invasive procedures or are about to undergo surgery or other invasive procedures, such as lumbar puncture. Patients with blood dyscrasias or inherited disorders of hemostasis. Patients with a history of hemorrhagic tendencies or prior serious hemorrhagic events such as hemorrhage within the cranium, eye, spinal cord, retroperitoneum, or gastrointestinal tract.

2. Laboratory evidence at screening of clinically significant active bleeding, such as unexplained positive occult blood in stool, or unexplained positive urinary blood that is more than trace positive for hemoglobin.

3. Concomitant use of other anticoagulant or antiplatelet agents that may add to the hemostatic burden such as clopidogrel, ticlopidine, heparin or low molecular weight heparin (LMWH), or regular use of non selective long acting NSAIDs that cannot be discontinued prior to initiating ATI 5923/warfarin dosing (daily use of 81-100 mg aspirin is allowed).

4. A life expectancy of < 1 year, end stage renal failure requiring dialysis, end stage pulmonary disease requiring home oxygen, severe heart failure (NYHA class IV).

5. Dementia, severe psychiatric disorder, or ongoing alcohol or substance abuse.

6. Laboratory screening values indicating severe anemia (Hb < 10 gm/L), thrombocytopenia (platelet count < 90,000/mcL), or active liver disease.

7. Patients with conditions that will interfere with determination of the INR using the INRatio device, i.e., hematocrit <30% or >55%. Patients with the antiphospholipid syndrome may have abnormal INR results and should not be enrolled.

8. History of non disabling ischemic stroke within the last 3 months, prior major disabling ischemic stroke, or any history of intracranial bleeding.

9. Pregnant or nursing women or women of childbearing potential who will not use adequate contraception, such as oral or implantable contraceptives, IUD, or barrier methods (IUD or condom) with spermicide.

10. Currently participating in another clinical trial at screening, treatment with an investigational drug within 30 days of the first dose of study medication, or patients who previously participated in an ATI-5923 trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ARYx Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

ARYx Therapeutics, Inc

Locations

Birmingham Heart Clinic, PC

Birmingham, Alabama, United States

Cardiology PC

Birmingham, Alabama, United States

The Heart Center, PC

Huntsville, Alabama, United States

Mobile Heart Specialists, PC

Mobile, Alabama, United States

Southwest Heart

Tucson, Arizona, United States

Escondido Cardiology Associates

Escondido, California, United States

University of California San Diego Medical Center

San Diego, California, United States

Progressive Clinical Research

Vista, California, United States

New West Physicians Clinical Research

Golden, Colorado, United States

Cardiology Associates of Fairfield County, PC

Norwalk, Connecticut, United States

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Cardiology Associates of Fairfield County, PC

Trumbull, Connecticut, United States

Florida Research Network, LLC

Gainesville, Florida, United States

Nature Coast Clinical Research

Inverness, Florida, United States

Jacksonville Heart Center - Pavillon

Jacksonville, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Jacksonville Heart Center - South

Jacksonville, Florida, United States

St. Luke's Cardiology Associates

Jacksonville, Florida, United States

Jacksonville Heart Center

Jacksonville Beach, Florida, United States

Orlando Heart Center

Orlando, Florida, United States

The Heart and Vascular Institute of Florida

Safety Harbor, Florida, United States

Georgia Heart Specialists

Covington, Georgia, United States

Northeast Georgia Heart Center, PC

Gainesville, Georgia, United States

Fox Valley Clinical Research Center, LLC

Aurora, Illinois, United States

Illinois Heart and Lung Research Center

Normal, Illinois, United States

DuPage Medical Group

Winfield, Illinois, United States

Community Clinical Research Center

Anderson, Indiana, United States

McFarland Clinic PC

Ames, Iowa, United States

Heart and Vascular Clinic

Lacombe, Louisiana, United States

Androscoggin Cardiology Associates

Auburn, Maine, United States

Endeavor Medical Research, PLC

Alpena, Michigan, United States

Steljes Cardiology, PC

Henderson, Nevada, United States

Cardiovascular Research Institute, LLC

Canton, Ohio, United States

Plaza Medical Group, PC

Oklahoma City, Oklahoma, United States

Bend Memorial Clinic

Bend, Oregon, United States

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, United States

Internal Medicine of Greer

Greer, South Carolina, United States

Medical Associates Clinic, LLP

Pierre, South Dakota, United States

Cardiovascular Research Institute of Dallas

Dallas, Texas, United States

York Clinical Research

Norfolk, Virginia, United States

Daniel Gottlieb, MD

Burien, Washington, United States

Countries

United States

Related Links

http://www.aryx.com/wt/page/ati5923

EmbraceAC Study Site

Other Identifiers

CLN-505

Identifier Type: -

Identifier Source: org_study_id