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

AstraZeneca

Status and phase: Terminated; Phase 2

Conditions: Stroke Prevention in Patients With Atrial Fibrillation

Treatments: Drug: EXANTA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00206063

D4004C00004

SH-TPA-0004

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)