Status:
COMPLETED
Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation
Lead Sponsor:
AstraZeneca
Conditions:
Nonvalvular Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of AZD0837 compare...
Eligibility Criteria
Inclusion
- Nonvalvular AF (NVAF) verified by at least two ECGs in the last year separated by at least one week.
- Previous cerebral ischemic attack (stroke or TIA, \>30 days prior to randomization)
- Previous systemic embolism.
- Symptomatic congestive heart failure (CHF)
- Impaired left ventricular systolic function
- Diabetes mellitus
- Hypertension requiring anti-hypertensive treatment.
Exclusion
- AF secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism
- Known contraindication to VKA treatment
- Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than AF requiring chronic anticoagulation treatment
- Conditions associated with increased risk of major bleeding for example: history of intracranial bleeding, history of bleeding gastrointestinal disorder or major surgical procedure or trauma two weeks prior to randomization
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
1084 Patients enrolled
Trial Details
Trial ID
NCT00684307
Start Date
February 1 2007
End Date
June 1 2008
Last Update
March 23 2012
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