Long Term Open Follow-up With H376/95 vs. Warfarin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00206063
Recruitment Status : Terminated (Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety.)
First Posted : September 21, 2005
Last Update Posted : November 15, 2010
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Brief Summary:
The purpose of this study is to evaluate tolerability of long-term treatment with ximelagatran compared to standard treatment with warfarin.

Condition or disease Intervention/treatment Phase
Stroke Prevention in Patients With Atrial Fibrillation Drug: EXANTA Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Long-Term Treatment With the Oral Direct Thrombin Inhibitor Ximelagatran, Compared to Warfarin, as Stroke Prophylaxis in Patients With Atrial Fibrillation. A Long Term Follow-Up Study
Study Start Date : August 1999
Primary Completion Date : June 2004
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Warfarin
U.S. FDA Resources

Intervention Details:
    Drug: EXANTA
    Other Name: Ximelagatran

Primary Outcome Measures :
  1. Number of Adverse Events, with special regard to bleeding, thromboembolic events and discontinuation of treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent.
  • Completion of the study SH-TPA-0002, history of chronic atrial fibrillation (i.e. rapidly beating heart), at least one risk factor for stroke (e.g. high blood pressure, age over 65, previous stroke or similar attack, diabetes or coronary heart disease)

Exclusion Criteria:

  • Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00206063

United States, California
Research Site
Palo Alto, California, United States
Research Site
Oostduinkerke, Belgium
Czech Republic
Research Site
Helsingor, Czech Republic
Research Site
Most, Czech Republic
Research Site
Plzeo, Czech Republic
Research Site
Poibram, Czech Republic
Research Site
Prague, Czech Republic
Research Site
Arhus, Denmark
Research Site
Odense, Denmark
Research Site
Kuopio, Finland
Research Site
Savonlinna, Finland
Research Site
Hamar, Norway
Research Site
Oslo, Norway
Research Site
Plock, Poland
Research Site
Siedice, Poland
Research Site
Warsaw, Poland
Research Site
Lund, Sweden
United Kingdom
Research Site
Leicester, United Kingdom
Research Site
Newcastle, United Kingdom
Sponsors and Collaborators
AstraZeneca Identifier: NCT00206063     History of Changes
Other Study ID Numbers: SH-TPA-0004
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 15, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action