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

March 20, 2012 updated by: AstraZeneca

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Research Site
      • Arhus N, Denmark
        • Research Site
      • Copenhagen, Denmark
        • Research Site
      • Esbjerg, Denmark
        • Research Site
      • Frederikssund, Denmark
        • Research Site
      • Horsens, Denmark
        • Research Site
      • Kobenhavn, Denmark
        • Research Site
      • Silkeborg, Denmark
        • Research Site
      • Svendborg, Denmark
        • Research Site
  • Norway
      • Elverum, Norway
        • Research Site
      • Gjettum, Norway
        • Research Site
      • Kongsberg, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Stovner, Norway
        • Research Site
      • Straume, Norway
        • Research Site
  • Poland
      • Bytom, Poland
        • Research Site
      • Czestochowa, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Ostrow Mazowiecka, Poland
        • Research Site
      • Otwock, Poland
        • Research Site
      • Plock, Poland
        • Research Site
      • Ruda Slaska, Poland
        • Research Site
      • Sopot, Poland
        • Research Site
      • Torun, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
  • Sweden
      • Boras, Sweden
        • Research Site
      • Goteborg, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
      • Malmo, Sweden
        • Research Site
      • Molndal, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom
        • Research Site
      • Eastbourne, United Kingdom
        • Research Site
      • Newcastle Upon Tyne, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
28 week (randomisation visit to last follow up visit in study) according to protocols
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
24 weeks (randomisation visit to last treatment visit)
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
28 weeks (randomisation visit to last follow up visit)
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
24 weeks (randomisation visit to last treatment visit) according to protocol
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
28 weeks (randomisation visit to last follow up visit) according to protocol

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Number of patients with a bleeding event while on study drug. Patients with multiple bleeding events are counted once
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)
Individual change in Creatinine level (umil/L) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
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)
Number of patients while on study drug with Alanine aminotransferase (ALAT)>=3 times upper limit of normal.
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)
Number of patients while on study drug with Bilirubin>=2 times upper limit of normal.
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
Assessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit
4 weeks after baseline according to protocol
Plasma Concentration of AR-H067637XX (Active Metabolite)
Time Frame: 4 weeks after baseline according to protocol
Assessment of plasma concentration of AR-H067637XX (active metabolite) made on the week 4 visit
4 weeks after baseline according to protocol
Change in D-Dimer Level
Time Frame: 4 weeks according to protocol.(baseline to week 4 visit)
Individual change in D-Dimer level (ng/ml) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
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)
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)
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)
Individual change in Ecarin clotting time (ECT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
4 weeks according to protocol.(baseline to week 4 visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gregory Y Lip, MD, Birmingham City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D1250C00051

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings