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

Phase 2TerminatedNCT00206063

AstraZeneca220 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

220

Conditions

Stroke Prevention in Patients With Atrial Fibrillation

Interventions

EXANTADRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (19)

Research Site

Palo Alto, California, United States

Research Site

Oostduinkerke, Belgium

Research Site

Helsingor, Czechia

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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