Clinical trial NCT00645853: Long-term Safety in Atrial Fibrillation Patients
Official title: Long-term Treatment With the Oral Direct Thrombin Inhibitor AZD0837, Compared to Vitamin-K Antagonists, as Stroke Prevention in Patients With Non-valvular Atrial Fibrillation and One or More Risk Factors for Stroke and Systemic Embolic Events. A 5-year Follow-up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Persistent or Permanent Nonvalvular Atrial Fibrillation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 523
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period
timeFrame: 154-711 days on treatment
Secondary outcomes:
measure: Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline
timeFrame: From baseline to Follow up
measure: Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline
timeFrame: From baseline to Follow up
measure: Creatinine: Absolute Change From Baseline, at End of Treatment
timeFrame: Baseline and End of treatment
measure: D-dimer:Median and Quartile Range at End of Treatment
timeFrame: End of treatment
measure: Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment
timeFrame: Baseline and End of treatment
measure: Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment
timeFrame: Baseline and End of Treatment
measure: AZD0837: Plasma Concentration of AZD0837 at End of Treatment
timeFrame: End of treatment
measure: AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment
timeFrame: 154-711 days on treatment
Other outcomes:
Locations:
Study officials:
affiliation: Head of Cardiology at Heart Centre Aalborg Aarhus University Hospital DK 9100 Aalborg Denmark
name: Lars Hvilstedt Rasmussen, MD, PhD, FESC
role: PRINCIPAL_INVESTIGATOR
References: