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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00206063

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: Ximelagatran	Phase II

MedlinePlus related topics: Blood Thinners

Drug Information available for: Warfarin Warfarin potassium Warfarin sodium Ximelagatran

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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

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:	June 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Eligibility

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

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
Most, Czech Republic
Research Site
Poibram, Czech Republic
Research Site
Prague, Czech Republic
Research Site
Plzeo, Czech Republic
Research Site
Helsingor, Czech Republic
Denmark
Research Site
Odense, Denmark
Research Site
Arhus, Denmark
Finland
Research Site
Kuopio, Finland
Research Site
Savonlinna, Finland
Norway
Research Site
Oslo, Norway
Research Site
Hamar, Norway
Poland
Research Site
Siedice, Poland
Research Site
Warsaw, Poland
Research Site
Plock, Poland
Sweden
Research Site
Lund, Sweden
United Kingdom
Research Site
Leicester, United Kingdom
Research Site
Newcastle, United Kingdom

Sponsors and Collaborators

AstraZeneca

More Information

Study ID Numbers:	D4004C00004, SH-TPA-0004
Study First Received:	September 13, 2005
Last Updated:	May 2, 2008
ClinicalTrials.gov Identifier:	NCT00206063
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thrombin
Heart Diseases
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases

Warfarin
Atrial Fibrillation
Ximelagatran
Brain Diseases
Cerebrovascular Disorders
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Anticoagulants
Pathologic Processes
Therapeutic Uses
Hematologic Agents

Nervous System Diseases
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009