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

NCT00691470 | Unknown Phase 2 DMC

• 1 other identifier: CLN-505
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 41

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.

Conditions

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

Keywords

Anticoagulation; Vitamin K-dependent clotting factor inhibitor; Coumadin; Warfarin; Atrial fibrillation; Prosthetic heart valve; Venous thromboembolic disease; Myocardial infarction or cardiomyopathy; Patients with one or more of the following indications for chronic warfarin anticoagulation:; Atrial fibrillation (paroxysmal, persistent or permanent, not due to a reversible cause, documented by ECG) or atrial flutter;; A prosthetic heart valve in the aortic or mitral position that requires chronic anticoagulation;; A history of venous thromboembolic disease (DVT and/or PE) requiring long term anticoagulation (> 6 months);; A history of myocardial infarction or cardiomyopathy requiring anticoagulation.; Currently receiving chronic warfarin therapy for another indication not listed, with Sponsor approval.

Outcome Measures

Primary Outcomes (1)

• Percent of time INR is in therapeutic range after the exclusion of the first 4 weeks of treatment, using the linear interpolation method of Rosendaal(Rosendaal, 1993).

  After the first month through end of study.

Secondary Outcomes (3)

• The proportion of all study recorded INR values that are within the target range, after the exclusion of the INR values from the first 4 weeks of treatment

  After the first month through end of study

• Proportion of time patients have significant deviations from therapeutic INR range.

  After the first month through end of study

• A composite of the following clinically important outcome events

  After the first month through end of study

Study Arms (2)

1. ATI-5923

EXPERIMENTAL

Dose adjusted ATI-5923

Drug: ATI-5923

2. Coumadin

ACTIVE COMPARATOR

Dose adjusted Coumadin (warfarin)

Drug: Coumadin (warfarin)

Interventions

ATI-5923 DRUG

Dose Adjusted based on INR.

1. ATI-5923

Coumadin (warfarin) DRUG

Dose adjusted based on INR.

2. Coumadin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• Atrial fibrillation (paroxysmal, persistent or permanent, not due to a reversible cause, documented by ECG) or atrial flutter.
• A prosthetic heart valve in the aortic or mitral position that requires chronic anticoagulation.
• A history of venous thromboembolic disease (DVT and/or PE) requiring long term anticoagulation (\> 6 months).
• A history of myocardial infarction or cardiomyopathy requiring anticoagulation.
• Currently receiving chronic warfarin therapy for another indication not listed, with Sponsor approval.
• Male or female greater than 18 years of age.
• Able and willing to sign IRB approved written informed consent to participate in the study.
• Able and willing to follow instructions, to comply with protocol requirements, and to attend required study visits.

You may not qualify if:

• 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.
• 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.
• 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).
• 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).
• Dementia, severe psychiatric disorder, or ongoing alcohol or substance abuse.
• Laboratory screening values indicating severe anemia (Hb \< 10 gm/L), thrombocytopenia (platelet count \< 90,000/mcL), or active liver disease.
• 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.
• History of non disabling ischemic stroke within the last 3 months, prior major disabling ischemic stroke, or any history of intracranial bleeding.
• 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.
• 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.

Sponsors & Collaborators

• ARYx Therapeutics: lead

Study Sites (41)

Birmingham Heart Clinic, PC

Birmingham, Alabama, 35235, United States

Location

Cardiology PC

Birmingham, Alabama, 36693, United States

Location

The Heart Center, PC

Huntsville, Alabama, 35801, United States

Location

Mobile Heart Specialists, PC

Mobile, Alabama, 36693, United States

Location

Southwest Heart

Tucson, Arizona, 85717, United States

Location

Escondido Cardiology Associates

Escondido, California, 92025, United States

Location

University of California San Diego Medical Center

San Diego, California, 92103, United States

Location

Progressive Clinical Research

Vista, California, 92083, United States

Location

New West Physicians Clinical Research

Golden, Colorado, 80401, United States

Location

Cardiology Associates of Fairfield County, PC

Norwalk, Connecticut, 06851, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

Cardiology Associates of Fairfield County, PC

Trumbull, Connecticut, 06611, United States

Location

Florida Research Network, LLC

Gainesville, Florida, 32605, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

Jacksonville Heart Center - Pavillon

Jacksonville, Florida, 32207, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Jacksonville Heart Center - South

Jacksonville, Florida, 32216, United States

Location

St. Luke's Cardiology Associates

Jacksonville, Florida, 32216, United States

Location

Jacksonville Heart Center

Jacksonville Beach, Florida, 32250, United States

Location

Orlando Heart Center

Orlando, Florida, 32806, United States

Location

The Heart and Vascular Institute of Florida

Safety Harbor, Florida, 34695, United States

Location

Georgia Heart Specialists

Covington, Georgia, 30014, United States

Location

Northeast Georgia Heart Center, PC

Gainesville, Georgia, 30501, United States

Location

Fox Valley Clinical Research Center, LLC

Aurora, Illinois, 60504, United States

Location

Illinois Heart and Lung Research Center

Normal, Illinois, 61761, United States

Location

DuPage Medical Group

Winfield, Illinois, 60190, United States

Location

Community Clinical Research Center

Anderson, Indiana, 46011, United States

Location

McFarland Clinic PC

Ames, Iowa, 50010, United States

Location

Heart and Vascular Clinic

Lacombe, Louisiana, 70445, United States

Location

Androscoggin Cardiology Associates

Auburn, Maine, 04210, United States

Location

Endeavor Medical Research, PLC

Alpena, Michigan, 49707, United States

Location

Steljes Cardiology, PC

Henderson, Nevada, 89704, United States

Location

Cardiovascular Research Institute, LLC

Canton, Ohio, 44710, United States

Location

Plaza Medical Group, PC

Oklahoma City, Oklahoma, 73112, United States

Location

Bend Memorial Clinic

Bend, Oregon, 97701, United States

Location

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

Location

Internal Medicine of Greer

Greer, South Carolina, 29651, United States

Location

Medical Associates Clinic, LLP

Pierre, South Dakota, 57501, United States

Location

Cardiovascular Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

York Clinical Research

Norfolk, Virginia, 23510, United States

Location

Daniel Gottlieb, MD

Burien, Washington, 98166, United States

Location

Related Links

• EmbraceAC Study Site

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Myocardial Infarction; Cardiomyopathies

Interventions

tecarfarin; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 5, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 2, 2010

Record last verified: 2008-10

Locations

US (41)