Persistent or Permanent Nonvalvular Atrial FibrillationPhase 2NCT00645853
Long-term Safety in Atrial Fibrillation Patients
A Phase 2 study testing AZD0837 and VKA INR 2-3 in people with Persistent or Permanent Nonvalvular Atrial Fibrillation, run by AstraZeneca.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent or Permanent Nonvalvular Atrial Fibrillation
- What is being tested?
- AZD0837 and VKA INR 2-3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 523 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to May 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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).
- Being tested
- AZD0837, VKA INR 2-3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0837Drug
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 2-3Drug
Also called warfarin
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD0837 |
| 2 | Active comparator | Not described Receives: Drug: VKA INR 2-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period
Participants
Measured: 154-711 days on treatment
Secondary outcomes (8)
Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline
ULN=Upper limit of Normal
Measured: From baseline to Follow up
Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline
Measured: From baseline to Follow up
Creatinine: Absolute Change From Baseline, at End of Treatment
Measured: Baseline and End of treatment
D-dimer:Median and Quartile Range at End of Treatment
Median (Lower Quartile-Upper Quartile ), ng/mL
Measured: End of treatment
Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment
Median Full range, Seconds
Measured: Baseline and End of treatment
Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment
Measured: Baseline and End of Treatment
AZD0837: Plasma Concentration of AZD0837 at End of Treatment
Measured: End of treatment
AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment
Measured: 154-711 days on treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Persistent or Permanent Nonvalvular Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 523 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars Hvilstedt Rasmussen, MD, PhD, FESC, Principal investigator, Head of Cardiology at Heart Centre Aalborg Aarhus University Hospital DK 9100 Aalborg Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645853
- Sponsor's protocol ID
- D1250C00042
- Status last verified
- Mar 2012
- First submitted
- 19 Mar 2008
- Last updated
- 23 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00645853
- Acronym / sponsor ID
- D1250C00042
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 523 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 28 Mar 2008 (estimated)
- Results
- Posted 6 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD0837 |
| 2 | Active comparator | Drug: VKA INR 2-3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0837Treatment 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 | Drug | 1 |
| VKA INR 2-3Also: warfarinVitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5 | Drug | 2 |
Primary outcome
Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period
Time frame: 154-711 days on treatment
Participants
8 secondary outcomes
Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline
Time frame: From baseline to Follow up
Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline
Time frame: From baseline to Follow up
Creatinine: Absolute Change From Baseline, at End of Treatment
Time frame: Baseline and End of treatment
D-dimer:Median and Quartile Range at End of Treatment
Time frame: End of treatment
Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment
Time frame: Baseline and End of treatment
Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment
Time frame: Baseline and End of Treatment
AZD0837: Plasma Concentration of AZD0837 at End of Treatment
Time frame: End of treatment
AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment
Time frame: 154-711 days on treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Hvilstedt Rasmussen, MD, PhD, FESC principal investigator
Head of Cardiology at Heart Centre Aalborg Aarhus University Hospital DK 9100 Aalborg Denmark
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD0837 and VKA INR 2-3 in people with Persistent or Permanent Nonvalvular Atrial Fibrillation, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period (time frame: 154-711 days on treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2012.