Long-term Safety in Atrial Fibrillation Patients

NCT00645853 | Completed Phase 2 Results DMC

• 1 other identifier: D1250C00042
• Study Type: interventional
• Target: 523
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Persistent or Permanent Nonvalvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period

  Participants

  154-711 days on treatment

Secondary Outcomes (8)

• Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline

  From baseline to Follow up

• Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline

  From baseline to Follow up

• Creatinine: Absolute Change From Baseline, at End of Treatment

  Baseline and End of treatment

• D-dimer:Median and Quartile Range at End of Treatment

  End of treatment

• Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment

  Baseline and End of treatment

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD0837

2

ACTIVE COMPARATOR

Drug: VKA INR 2-3

Interventions

AZD0837 DRUG

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

1

VKA INR 2-3 DRUG

Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5

Also known as: warfarin

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Conditions associated with increased risk of major bleeding.

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Interventions

AZD 0837; Warfarin

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Lars Hvilstedt Rasmussen, MD, PhD, FESC

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 28, 2008
• Study Start: October 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 23, 2012
• Results First Posted: March 6, 2012

Record last verified: 2012-03