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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00206063

Enrollment

220

Registered

2005-09-21

Start date

1999-08-31

Completion date

2006-04-30

Last updated

2010-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Prevention in Patients With Atrial Fibrillation

Brief summary

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

Interventions

DRUGEXANTA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Belgium, Czechia, Denmark, Finland, Norway, Poland, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026