Persistent or Permanent Non-valvular Atrial FibrillationPhase 2NCT00623779

Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA)

A Phase 2 study testing AZD0837 and Aspirin in people with Persistent or Permanent Non-valvular Atrial Fibrillation, run by AstraZeneca at 38 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the safety and tolerability of AZD0837 in patients with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for up to 3 months. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Persistent or Permanent Non-valvular Atrial Fibrillation
What is being tested?: AZD0837 and Aspirin
Type of treatment: Pill or oral medicine
How many people: 128 participants
Where: 38 sitesin 6 countries
Study dates: Oct 2007to Oct 2008
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

Either one of the following risk factors is sufficient for inclusion (high risk patient)
Previous cerebral ischaemic attack (stroke or transient ischaemic attack (TIA), >30 days prior to randomization)
Previous systemic embolism or at least one of the following risk factors are needed for inclusion: Age ≥75 years
Symptomatic congestive heart failure
Impaired left ventricular systolic function
Diabetes mellitus; Hypertension requiring anti-hypertensive treatment
In addition to AF the patient must be appropriate for but unable or unwilling to take VKA therapy

Who cannot join

Presence of a clinically significant valvular heart disease;; Stroke or TIA and/or systemic embolism within the previous 30 days prior to randomization
Conditions associated with increased risk of major bleeding

Trial locations and contacts

38 sites in 6 countries.

Country

City, postcode or hospital

38 sites in 6 countries

Poland13 sites

Research Site
Bytom
Research Site
Częstochowa
Research Site
Krakow
Research Site
Lodz
Research Site
Lublin
Research Site
Ostrów Mazowiecka
Research Site
Otwock
Research Site
Płock
Research Site
Ruda Śląska
Research Site
Sopot
Research Site
Torun
Research Site
Warsaw
Research Site
Wroclaw

Other trials in Poland

Denmark8 sites

Research Site
Aalborg
Research Site
Arhus N
Research Site
Copenhagen
Research Site
Esbjerg
Research Site
Frederikssund
Research Site
Horsens
Research Site
Silkeborg
Research Site
Svendborg

Other trials in Denmark

Norway6 sites

Research Site
Elverum
Research Site
Gjettum
Research Site
Kongsberg
Research Site
Oslo
Research Site
Stovner
Research Site
Straume

Other trials in Norway

Sweden6 sites

Research Site
Borås
Research Site
Gothenburg
Research Site
Lund
Research Site
Malmö
Research Site
Mölndal
Research Site
Stockholm

Other trials in Sweden

United Kingdom3 sites

Research Site
Birmingham
Research Site
Eastbourne
Research Site
Newcastle upon Tyne

Other trials in United Kingdom

Russia2 sites

Research Site
Moscow
Research Site
Saint Petersburg

Other trials in Russia

About this study

Official title: A Controlled, Randomized, Parallel , Multi-centre Feasibility Study of the Oral Direct Thrombin Inhibitor, AZD0837, Given as ER Formulation, in the Prevention of Stroke and Systolic Embolic Events in Patients With Atrial Fibrillation, Who Are Appropriate for But Unable/Unwilling to Take VKA Therapy

The purpose of this study is to assess the safety and tolerability of AZD0837 in patients with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for up to 3 months.

Conditions: Persistent or Permanent Non-valvular Atrial Fibrillation
Being tested: AZD0837, Aspirin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD0837Drug
ER formulation
AspirinDrug
Oral form

What is being measured

The primary outcome is the main question the study is designed to answer.

Premature Discontinuation of Study or Study Drug Due to Any Reason
The premature discontinuation of study or study drug due to any reason
Measured: 28 week (randomisation visit to last follow up visit in study) according to protocols
Premature Discontinuation of Study Drug Due to Any Reason
The premature discontinuation of study drug due to any reason
Measured: 24 weeks (randomisation visit to last treatment visit)
Premature Discontinuation of Study Due to Any Reason
|The premature discontinuation of study due to any reason
Measured: 28 weeks (randomisation visit to last follow up visit)
Compliance With Study Drug
[(number of doses dispensed-number of doses returned)/number of days between visits]*100
Measured: 24 weeks (randomisation visit to last treatment visit) according to protocol
Compliance With Study Visits/Assessments
(number of visits attended acroos the time of study divided by the number of expected visits according to the time of entry into study)*100
Measured: 28 weeks (randomisation visit to last follow up visit) according to protocol

Secondary outcomes (9)

Bleeding Events
Number of patients with a bleeding event while on study drug. Patients with multiple bleeding events are counted once
Measured: 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)
Change in Creatinine Level
Individual change in Creatinine level (umil/L) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Measured: 4 weeks according to protocol (randomisation visit to week 4 visit)
Alanine Aminotransferase (ALAT)
Number of patients while on study drug with Alanine aminotransferase (ALAT)>=3 times upper limit of normal.
Measured: 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)
Bilirubin
Number of patients while on study drug with Bilirubin>=2 times upper limit of normal.
Measured: 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)
Plasma Concentration of AZD0837 (Prodrug)
Assessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit
Measured: 4 weeks after baseline according to protocol
Plasma Concentration of AR-H067637XX (Active Metabolite)
Assessment of plasma concentration of AR-H067637XX (active metabolite) made on the week 4 visit
Measured: 4 weeks after baseline according to protocol
Change in D-Dimer Level
Individual change in D-Dimer level (ng/ml) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Measured: 4 weeks according to protocol.(baseline to week 4 visit)
Activated Partial Thromboplastin Time (APTT)
Individual change in Activated partial thromboplastin time (APTT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Measured: 4 weeks according to protocol.(baseline to week 4 visit)
Ecarin Clotting Time (ECT)
Individual change in Ecarin clotting time (ECT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Measured: 4 weeks according to protocol.(baseline to week 4 visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Oct 2008

First posted26 Feb 2008 (estimated)
Study startOct 2007
Primary completionOct 2008
Study completionOct 2008

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 Non-valvular 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00623779
Sponsor's protocol ID: D1250C00051
Status last verified: Mar 2012
First submitted: 15 Feb 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: A Controlled, Randomized, Parallel , Multi-centre Feasibility Study of the Oral Direct Thrombin Inhibitor, AZD0837, Given as ER Formulation, in the Prevention of Stroke and Systolic Embolic Events in Patients With Atrial Fibrillation, Who Are Appropriate for But Unable/Unwilling to Take VKA Therapy
ClinicalTrials.gov ID: NCT00623779
Acronym / sponsor ID: D1250C00051
Conditions: Persistent or Permanent Non-valvular Atrial Fibrillation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 26 Feb 2008 (estimated)
Results: Posted 28 Jul 2011

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 assess the safety and tolerability of AZD0837 in patients with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for up to 3 months.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Either one of the following risk factors is sufficient for inclusion (high risk patient)
Previous cerebral ischaemic attack (stroke or transient ischaemic attack (TIA), >30 days prior to randomization)
Previous systemic embolism or at least one of the following risk factors are needed for inclusion: Age ≥75 years
Symptomatic congestive heart failure
Impaired left ventricular systolic function

Key exclusion criteria (2 listed)

Presence of a clinically significant valvular heart disease;; Stroke or TIA and/or systemic embolism within the previous 30 days prior to randomization
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
AZD0837ER formulation	Drug	–
AspirinOral form	Drug	–

Primary outcome

Premature Discontinuation of Study or Study Drug Due to Any Reason
Time frame: 28 week (randomisation visit to last follow up visit in study) according to protocols
The premature discontinuation of study or study drug due to any reason
Premature Discontinuation of Study Drug Due to Any Reason
Time frame: 24 weeks (randomisation visit to last treatment visit)
The premature discontinuation of study drug due to any reason
Premature Discontinuation of Study Due to Any Reason
Time frame: 28 weeks (randomisation visit to last follow up visit)
|The premature discontinuation of study due to any reason
Compliance With Study Drug
Time frame: 24 weeks (randomisation visit to last treatment visit) according to protocol
[(number of doses dispensed-number of doses returned)/number of days between visits]*100
Compliance With Study Visits/Assessments
Time frame: 28 weeks (randomisation visit to last follow up visit) according to protocol
(number of visits attended acroos the time of study divided by the number of expected visits according to the time of entry into study)*100

9 secondary outcomes

Bleeding Events
Time frame: 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)
Change in Creatinine Level
Time frame: 4 weeks according to protocol (randomisation visit to week 4 visit)
Alanine Aminotransferase (ALAT)
Time frame: 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)
Bilirubin
Time frame: 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)
Plasma Concentration of AZD0837 (Prodrug)
Time frame: 4 weeks after baseline according to protocol
Plasma Concentration of AR-H067637XX (Active Metabolite)
Time frame: 4 weeks after baseline according to protocol
Change in D-Dimer Level
Time frame: 4 weeks according to protocol.(baseline to week 4 visit)
Activated Partial Thromboplastin Time (APTT)
Time frame: 4 weeks according to protocol.(baseline to week 4 visit)
Ecarin Clotting Time (ECT)
Time frame: 4 weeks according to protocol.(baseline to week 4 visit)

Results and safety

Results posted to the registry on 28 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD0837 150 mg	41	38
AZD0837 300 mg	42	39
Standard Therapy	45	44

Primary outcome: Premature Discontinuation of Study or Study Drug Due to Any Reason

Time frame: 28 week (randomisation visit to last follow up visit in study) according to protocols. Number. Unit: Participants

Measure	AZD0837 150 mg n = 41	AZD0837 300 mg n = 42	Standard Therapy n = 45
Value	4	6	3

Primary outcome: Premature Discontinuation of Study Drug Due to Any Reason

Time frame: 24 weeks (randomisation visit to last treatment visit). Number. Unit: Participants

Measure	AZD0837 150 mg n = 41	AZD0837 300 mg n = 42	Standard Therapy n = 45
Value	3	3	1

Primary outcome: Premature Discontinuation of Study Due to Any Reason

Time frame: 28 weeks (randomisation visit to last follow up visit). Number. Unit: Participants

Measure	AZD0837 150 mg n = 41	AZD0837 300 mg n = 42	Standard Therapy n = 45
Value	4	4	2

Primary outcome: Compliance With Study Drug

Time frame: 24 weeks (randomisation visit to last treatment visit) according to protocol. Mean (Standard Deviation). Unit: Percentage

Measure	AZD0837 150 mg n = 41	AZD0837 300 mg n = 39	Standard Therapy n = 0
Value	96.95 (16.503)	99.82 (11.383)	–

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD0837 150 mg	2 of 41 (4.9%)	3 of 41 (7.3%)	Not reported
AZD0837 300 mg	3 of 41 (7.3%)	1 of 41 (2.4%)	Not reported
Standard Therapy	2 of 46 (4.3%)	1 of 46 (2.2%)	Not reported

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.

Gregory Y Lip, MD principal investigator

Birmingham City Hospital

38 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD0837 and Aspirin in people with Persistent or Permanent Non-valvular Atrial Fibrillation, run by AstraZeneca at 38 sites in 6 countries.

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 7 inclusion and 2 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.

Where is the study taking place?

The record lists 38 sites in Poland, Denmark, Norway, Sweden, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

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 28 Jul 2011). 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?

Premature Discontinuation of Study or Study Drug Due to Any Reason (time frame: 28 week (randomisation visit to last follow up visit in study) according to protocols). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00623779.

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.