Long Term Open Follow-up With H376/95 vs. Warfarin
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stroke Prevention in Patients With Atrial Fibrillation
Intervention: Ximelagatran (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: AstraZeneca
Summary
The purpose of this study is to evaluate tolerability of long-term treatment with
ximelagatran compared to standard treatment with warfarin.
Clinical Details
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 design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Primary outcome: Number of Adverse Events, with special regard to bleeding, thromboembolic events and discontinuation of treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Research Site, Oostduinkerke, Belgium
Research Site, Most, Czech Republic
Research Site, Poibram, Czech Republic
Research Site, Prague, Czech Republic
Research Site, Plzeo, Czech Republic
Research Site, Helsingor, Czech Republic
Research Site, Odense, Denmark
Research Site, Arhus, Denmark
Research Site, Kuopio, Finland
Research Site, Savonlinna, Finland
Research Site, Oslo, Norway
Research Site, Hamar, Norway
Research Site, Siedice, Poland
Research Site, Warsaw, Poland
Research Site, Plock, Poland
Research Site, Lund, Sweden
Research Site, Leicester, United Kingdom
Research Site, Newcastle, United Kingdom
Research Site, Palo Alto, California, United States
Additional Information
Starting date: August 1999
Ending date: June 2006
Last updated: May 2, 2008
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