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( Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety. )

First Received: September 13, 2005 Last Updated: April 9, 2009 History of Changes

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Blood Thinners

Drug Information available for: Warfarin Ximelagatran

U.S. FDA Resources

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

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

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

No publications provided

Study ID Numbers:	D4004C00004, SH-TPA-0004
Study First Received:	September 13, 2005
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00206063 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

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

Warfarin
Brain Diseases
Cerebrovascular Disorders
Atrial Fibrillation
Ximelagatran
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Heart Diseases
Anticoagulants
Hematologic Agents
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Brain Diseases

Cerebrovascular Disorders
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Atrial Fibrillation
Ximelagatran
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on September 11, 2009