Long-Term Safety in Atrial Fibrillation Patients - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00645853

Purpose

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).

Condition	Intervention	Phase
Paroxysmal Persistent or Permanent Nonvalvular Atrial Fibrillation	Drug: AZD0837 Drug: Vitamin-K Antagonists (warfarin)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Blood Thinners Vitamin K

Drug Information available for: Vitamin K Warfarin Warfarin sodium Warfarin potassium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To evaluate safety and tolerability of long-term treatment with AZD0837 compared to Vitamin-K Antagonist (VKA) in Atrial Fibrillation patients with a moderate to high risk of stroke and systemic embolic events. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the PK of AZD0837 and metabolites; To evaluate the effect of AZD0837 on PD markers and coagulation assays in Atrial Fibrillation patients with a moderate to high risk of stroke and systemic embolic events. [ Designated as safety issue: No ]

Enrollment:	523
Study Start Date:	October 2007
Study Completion Date:	May 2009

Arms	Assigned Interventions
Experimental: 1	Drug: AZD0837
Active Comparator: 2	Drug: Vitamin-K Antagonists (warfarin) Other Name: warfarin

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645853

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Lars Hvilstedt Rasmussen, MD, PhD, FESC

Head of Cardiology at Heart Centre Aalborg Aarhus University Hospital DK 9100 Aalborg Denmark

More Information

No publications provided

Responsible Party:	Karin Wåhlander - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00645853 History of Changes
Other Study ID Numbers:	D1250C00042
Study First Received:	March 19, 2008
Last Updated:	June 11, 2009
Health Authority:	Denmark: Danish Medicines Agency; Norway: Norwegian Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Ministry of Health and Social Development of the Russian Federation; Sweden: Medical Products Agency; Austria: Agency for Health and Food Safety; Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Antithrombins
Vitamin K
Vitamins
Warfarin
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on February 09, 2012