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

Primary Purpose

Atrial Fibrillation, Atrial Flutter, Venous Thromboembolic Disease

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ATI-5923
Coumadin (warfarin)
Sponsored by
ARYx Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring 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.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Birmingham Heart Clinic, PC
  • Cardiology PC
  • The Heart Center, PC
  • Mobile Heart Specialists, PC
  • Southwest Heart
  • Escondido Cardiology Associates
  • University of California San Diego Medical Center
  • Progressive Clinical Research
  • New West Physicians Clinical Research
  • Cardiology Associates of Fairfield County, PC
  • Stamford Therapeutics Consortium
  • Cardiology Associates of Fairfield County, PC
  • Florida Research Network, LLC
  • Nature Coast Clinical Research
  • Jacksonville Heart Center
  • Jacksonville Heart Center - Pavillon
  • Jacksonville Center for Clinical Research
  • Jacksonville Heart Center - South
  • St. Luke's Cardiology Associates
  • Orlando Heart Center
  • The Heart and Vascular Institute of Florida
  • Georgia Heart Specialists
  • Northeast Georgia Heart Center, PC
  • Fox Valley Clinical Research Center, LLC
  • Illinois Heart and Lung Research Center
  • DuPage Medical Group
  • Community Clinical Research Center
  • McFarland Clinic PC
  • Heart and Vascular Clinic
  • Androscoggin Cardiology Associates
  • Endeavor Medical Research, PLC
  • Steljes Cardiology, PC
  • Cardiovascular Research Institute, LLC
  • Plaza Medical Group, PC
  • Bend Memorial Clinic
  • Lankenau Institute for Medical Research
  • Internal Medicine of Greer
  • Medical Associates Clinic, LLP
  • Cardiovascular Research Institute of Dallas
  • York Clinical Research
  • Daniel Gottlieb, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1. ATI-5923

2. Coumadin

Arm Description

Dose adjusted ATI-5923

Dose adjusted Coumadin (warfarin)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
Proportion of time patients have significant deviations from therapeutic INR range.
A composite of the following clinically important outcome events

Full Information

First Posted
June 3, 2008
Last Updated
February 1, 2010
Sponsor
ARYx Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00691470
Brief Title
Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation
Acronym
EmbraceAC
Official Title
A Randomized, Double Blind Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
ARYx Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1. ATI-5923
Arm Type
Experimental
Arm Description
Dose adjusted ATI-5923
Arm Title
2. Coumadin
Arm Type
Active Comparator
Arm Description
Dose adjusted Coumadin (warfarin)
Intervention Type
Drug
Intervention Name(s)
ATI-5923
Intervention Description
Dose Adjusted based on INR.
Intervention Type
Drug
Intervention Name(s)
Coumadin (warfarin)
Intervention Description
Dose adjusted based on INR.
Primary Outcome Measure Information:
Title
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).
Time Frame
After the first month through end of study.
Secondary Outcome Measure Information:
Title
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
Time Frame
After the first month through end of study
Title
Proportion of time patients have significant deviations from therapeutic INR range.
Time Frame
After the first month through end of study
Title
A composite of the following clinically important outcome events
Time Frame
After the first month through end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Birmingham Heart Clinic, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Cardiology PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
36693
Country
United States
Facility Name
The Heart Center, PC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Mobile Heart Specialists, PC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36693
Country
United States
Facility Name
Southwest Heart
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85717
Country
United States
Facility Name
Escondido Cardiology Associates
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Progressive Clinical Research
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
New West Physicians Clinical Research
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Cardiology Associates of Fairfield County, PC
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Cardiology Associates of Fairfield County, PC
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Florida Research Network, LLC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Jacksonville Heart Center
City
Jacksonville Beach
State/Province
Florida
ZIP/Postal Code
32250
Country
United States
Facility Name
Jacksonville Heart Center - Pavillon
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Jacksonville Heart Center - South
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
St. Luke's Cardiology Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Orlando Heart Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
The Heart and Vascular Institute of Florida
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Facility Name
Georgia Heart Specialists
City
Covington
State/Province
Georgia
ZIP/Postal Code
30014
Country
United States
Facility Name
Northeast Georgia Heart Center, PC
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Fox Valley Clinical Research Center, LLC
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Illinois Heart and Lung Research Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
DuPage Medical Group
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Community Clinical Research Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
McFarland Clinic PC
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Heart and Vascular Clinic
City
Lacombe
State/Province
Louisiana
ZIP/Postal Code
70445
Country
United States
Facility Name
Androscoggin Cardiology Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Endeavor Medical Research, PLC
City
Alpena
State/Province
Michigan
ZIP/Postal Code
49707
Country
United States
Facility Name
Steljes Cardiology, PC
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89704
Country
United States
Facility Name
Cardiovascular Research Institute, LLC
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Plaza Medical Group, PC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Bend Memorial Clinic
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Lankenau Institute for Medical Research
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Internal Medicine of Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Medical Associates Clinic, LLP
City
Pierre
State/Province
South Dakota
ZIP/Postal Code
57501
Country
United States
Facility Name
Cardiovascular Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
York Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Daniel Gottlieb, MD
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.aryx.com/wt/page/ati5923
Description
EmbraceAC Study Site

Learn more about this trial

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

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