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

Primary Purpose

Stroke Prevention in Patients With Atrial Fibrillation

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EXANTA
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke Prevention in Patients With Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Outcomes

Primary Outcome Measures

Number of Adverse Events, with special regard to bleeding, thromboembolic events and discontinuation of treatment.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
November 10, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00206063
Brief Title
Long Term Open Follow-up With H376/95 vs. Warfarin
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 Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety.
Study Start Date
August 1999 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Prevention in Patients With Atrial Fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
EXANTA
Other Intervention Name(s)
Ximelagatran
Primary Outcome Measure Information:
Title
Number of Adverse Events, with special regard to bleeding, thromboembolic events and discontinuation of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Research Site
City
Palo Alto
State/Province
California
Country
United States
Facility Name
Research Site
City
Oostduinkerke
Country
Belgium
Facility Name
Research Site
City
Helsingor
Country
Czech Republic
Facility Name
Research Site
City
Most
Country
Czech Republic
Facility Name
Research Site
City
Plzeo
Country
Czech Republic
Facility Name
Research Site
City
Poibram
Country
Czech Republic
Facility Name
Research Site
City
Prague
Country
Czech Republic
Facility Name
Research Site
City
Arhus
Country
Denmark
Facility Name
Research Site
City
Odense
Country
Denmark
Facility Name
Research Site
City
Kuopio
Country
Finland
Facility Name
Research Site
City
Savonlinna
Country
Finland
Facility Name
Research Site
City
Hamar
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Plock
Country
Poland
Facility Name
Research Site
City
Siedice
Country
Poland
Facility Name
Research Site
City
Warsaw
Country
Poland
Facility Name
Research Site
City
Lund
Country
Sweden
Facility Name
Research Site
City
Leicester
Country
United Kingdom
Facility Name
Research Site
City
Newcastle
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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