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Atrial FibrillationPhase 2/3EmbraceACNCT00691470

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

A Phase 2/3 study testing ATI-5923 and Coumadin (warfarin) in people with Atrial Fibrillation and Atrial Flutter, run by ARYx Therapeutics at 41 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ATI-5923 and Coumadin (warfarin)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
41 sitesUnited States
Study dates
May 2008to Jun 2009
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • Endeavor Medical Research, PLC

    Alpena, Michigan, 49707

  • McFarland Clinic PC

    Ames, Iowa, 50010

  • Community Clinical Research Center

    Anderson, Indiana, 46011

  • Androscoggin Cardiology Associates

    Auburn, Maine, 04210

  • Fox Valley Clinical Research Center, LLC

    Aurora, Illinois, 60504

  • Bend Memorial Clinic

    Bend, Oregon, 97701

  • Birmingham Heart Clinic, PC

    Birmingham, Alabama, 35235

  • Cardiology PC

    Birmingham, Alabama, 36693

  • Daniel Gottlieb, MD

    Burien, Washington, 98166

  • Cardiovascular Research Institute, LLC

    Canton, Ohio, 44710

  • Georgia Heart Specialists

    Covington, Georgia, 30014

  • Cardiovascular Research Institute of Dallas

    Dallas, Texas, 75231

  • Escondido Cardiology Associates

    Escondido, California, 92025

  • Florida Research Network, LLC

    Gainesville, Florida, 32605

  • Northeast Georgia Heart Center, PC

    Gainesville, Georgia, 30501

  • New West Physicians Clinical Research

    Golden, Colorado, 80401

  • Internal Medicine of Greer

    Greer, South Carolina, 29651

  • Steljes Cardiology, PC

    Henderson, Nevada, 89704

  • The Heart Center, PC

    Huntsville, Alabama, 35801

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • Jacksonville Heart Center - Pavillon

    Jacksonville, Florida, 32207

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Jacksonville Heart Center - South

    Jacksonville, Florida, 32216

  • St. Luke's Cardiology Associates

    Jacksonville, Florida, 32216

  • Jacksonville Heart Center

    Jacksonville Beach, Florida, 32250

  • Heart and Vascular Clinic

    Lacombe, Louisiana, 70445

  • Mobile Heart Specialists, PC

    Mobile, Alabama, 36693

  • York Clinical Research

    Norfolk, Virginia, 23510

  • Illinois Heart and Lung Research Center

    Normal, Illinois, 61761

  • Cardiology Associates of Fairfield County, PC

    Norwalk, Connecticut, 06851

  • Plaza Medical Group, PC

    Oklahoma City, Oklahoma, 73112

  • Orlando Heart Center

    Orlando, Florida, 32806

  • Medical Associates Clinic, LLP

    Pierre, South Dakota, 57501

  • The Heart and Vascular Institute of Florida

    Safety Harbor, Florida, 34695

  • University of California San Diego Medical Center

    San Diego, California, 92103

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • Cardiology Associates of Fairfield County, PC

    Trumbull, Connecticut, 06611

  • Southwest Heart

    Tucson, Arizona, 85717

  • Progressive Clinical Research

    Vista, California, 92083

  • DuPage Medical Group

    Winfield, Illinois, 60190

  • Lankenau Institute for Medical Research

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

Official title: A Randomized, Double Blind Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation

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.

Read the 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.

Being tested
ATI-5923, Coumadin (warfarin)
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.
Medical subject headings
Atrial Fibrillation, Atrial Flutter, Myocardial Infarction, Cardiomyopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATI-5923Drug

    Dose Adjusted based on INR.

  • Coumadin (warfarin)Drug

    Dose adjusted based on INR.

Study groups in NCT00691470
Study groupRoleWhat they receive
1. ATI-5923ExperimentalDose adjusted ATI-5923
Receives: Drug: ATI-5923
2. CoumadinActive comparatorDose adjusted Coumadin (warfarin)
Receives: Drug: Coumadin (warfarin)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: After the first month through end of study.

Secondary outcomes (3)

  1. 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

    Measured: After the first month through end of study

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

    Measured: After the first month through end of study

  3. A composite of the following clinically important outcome events

    Measured: After the first month through end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionJun 2009 (estimated)
  4. Study completionJun 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00691470
Sponsor's protocol ID
CLN-505
Acronym
EmbraceAC
Status last verified
Oct 2008
First submitted
3 Jun 2008
Last updated
2 Feb 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ATI-5923 and Coumadin (warfarin) in people with Atrial Fibrillation and Atrial Flutter, run by ARYx Therapeutics at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00691470.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2010; AzTrials last refreshed its copy on 8 Nov 2026.

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