Long-term Safety in Atrial Fibrillation Patients

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Persistent or Permanent Nonvalvular Atrial Fibrillation

Treatments: Drug: AZD0837; Drug: VKA INR 2-3

Study type: Interventional

Funder types: Industry

Identifiers

NCT00645853

D1250C00042

Details and patient eligibility

About

The purpose of this study is to provide safety and tolerability data for AZD0837 during long-term treatment (5 years) in patients with non-valvular atrial fibrillation (AF) and one or more additional risk factors for stroke and systemic embolic events (moderate to high risk patients).

Enrollment: 523 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with paroxysmal, persistent or permanent Non Valvular Atrial Fibrillation with one or more additional risk factors for stroke and systemic embolic event
• completing treatment with study drug in D1250C00008.

Exclusion criteria

• Atrial Fibrillation secondary to reversible disorders, eg hyperthyroidism
• Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than Atrial Fibrillation requiring chronic anticoagulation treatment
• Myocardial infarction, heart surgery or percutaneous coronary intervention (PCI) within the previous three months prior to inclusion; Stroke and/or systemic embolism within the previous 30 days prior to inclusion
• Conditions associated with increased risk of major bleeding.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

523 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: AZD0837

2

Active Comparator group

Treatment:

Drug: VKA INR 2-3