Long-term Safety in Atrial Fibrillation Patients

Persistent or Permanent Nonvalvular Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645853
• Other study ID #: D1250C00042
• Status: Completed
• Phase: Phase 2
• First received: March 19, 2008
• Last updated: March 20, 2012
• Start date: October 2007
• Est. completion date: May 2009

Study information

• Verified date: March 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyNorway: Norwegian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationSweden: Medical Products AgencyAustria: Agency for Health and Food SafetyHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 523
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent or Permanent Nonvalvular Atrial Fibrillation

Intervention

Drug:
• AZD0837
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od
• VKA INR 2-3
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period	Participants	154-711 days on treatment	Yes
Secondary	Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline	ULN=Upper limit of Normal	From baseline to Follow up	Yes
Secondary	Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline		From baseline to Follow up	Yes
Secondary	Creatinine: Absolute Change From Baseline, at End of Treatment		Baseline and End of treatment	Yes
Secondary	D-dimer:Median and Quartile Range at End of Treatment	Median (Lower Quartile-Upper Quartile ), ng/mL	End of treatment	Yes
Secondary	Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment	Median Full range, Seconds	Baseline and End of treatment	Yes
Secondary	Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment		Baseline and End of Treatment	Yes
Secondary	AZD0837: Plasma Concentration of AZD0837 at End of Treatment		End of treatment	No
Secondary	AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment		154-711 days on treatment	No