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

This study has been terminated.
(Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00206063
First received: September 13, 2005
Last updated: November 10, 2010
Last verified: November 2010
  Purpose

The purpose of this study is to evaluate tolerability of long-term treatment with ximelagatran compared to standard treatment with warfarin.


Condition Intervention Phase
Stroke Prevention in Patients With Atrial Fibrillation
Drug: EXANTA
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 220
Study Start Date: August 1999
Study Completion Date: April 2006
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: EXANTA
    Other Name: Ximelagatran
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206063

Locations
United States, California
Research Site
Palo Alto, California, United States
Belgium
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
Denmark
Research Site
Arhus, Denmark
Research Site
Odense, Denmark
Finland
Research Site
Kuopio, Finland
Research Site
Savonlinna, Finland
Norway
Research Site
Hamar, Norway
Research Site
Oslo, Norway
Poland
Research Site
Plock, Poland
Research Site
Siedice, Poland
Research Site
Warsaw, Poland
Sweden
Research Site
Lund, Sweden
United Kingdom
Research Site
Leicester, United Kingdom
Research Site
Newcastle, United Kingdom
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00206063     History of Changes
Other Study ID Numbers: SH-TPA-0004, D4004C00004
Study First Received: September 13, 2005
Last Updated: November 10, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Antithrombins
Antithrombin Proteins
Ximelagatran
Warfarin
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014