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Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00684307
First received: May 22, 2008
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
Results First Received: August 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Nonvalvular Atrial Fibrillation
Interventions: Drug: AZD0837
Drug: Vitamin-K antagonist at INR 2-3

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study population included male and female participants >18 years of age with chronic non-valvular Atrial Fibrillation. The participants were recruited during the time period from 20 February 2007 to 5 June 2008 at medical clinics in Europe.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were enrolled in the study up to two weeks before randomisation and treatment assignment. Participants that were already treated with Vitamin K Antagonists (VKA) at the time of enrollment had their dose adjusted to achive INR <2.0 at the time of randomisation. If this was not achieved the participant was discontinued from the study.

Reporting Groups
  Description
150 mg od AZD0837 150 mg od
300 mg od AZD0837 300 mg od
450 mg od AZD0837 450 mg od
200 mg bd AZD0837 200 mg bd
VKA INR 2-3 No text entered.

Participant Flow:   Overall Study
    150 mg od     300 mg od     450 mg od     200 mg bd     VKA INR 2-3  
STARTED     164 [1]   151     156     160     318  
On Treatment Period Started     164     151     156     160     318  
On Treatment Period Completed     140 [2]   129     128     128     293  
COMPLETED     140     129     128     128     293  
NOT COMPLETED     24     22     28     32     25  
Adverse Event                 11                 6                 15                 16                 8  
Development of increasing Liver Function                 0                 2                 0                 1                 0  
Fullfillment of exclusion criteria                 1                 0                 0                 3                 1  
Incorrect enrolment or randomization                 4                 0                 0                 0                 0  
Interupted IP for more than 7 days                 0                 4                 1                 3                 3  
Severe non compliance to protocol                 1                 0                 0                 1                 2  
Participant not willing to continue                 7                 10                 11                 5                 8  
Criteria from the CSR                 0                 0                 1                 3                 3  
[1] Patients who received treatment
[2] Patients who completed treatment



  Baseline Characteristics
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Reporting Groups
  Description
150 mg od AZD0837 150 mg od
300 mg od AZD0837 300 mg od
450 mg od AZD0837 450 mg od
200 mg bd AZD0837 200 mg bd
VKA INR 2-3 No text entered.
Total Total of all reporting groups

Baseline Measures
    150 mg od     300 mg od     450 mg od     200 mg bd     VKA INR 2-3     Total  
Number of Participants  
[units: participants]
 		  164     151     156     160     318     949  
Age  
[units: Years]
Mean ± Standard Deviation 		  9.0  ± 69.9     9.0  ± 69.8     9.4  ± 69.3     9.4  ± 67.8     9.1  ± 68.3     9.18  ± 69.02  
Gender  
[units: Participants]
 		           
Female     47     47     49     53     103     299  
Male     117     104     107     107     215     650  



  Outcome Measures
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1.  Primary:   Bleeding Events   [ Time Frame: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit) ]
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2.  Primary:   Creatinine   [ Time Frame: 12 weeks according to protocol.(baseline to week 12 visit)  ]
  Show Outcome Measure 2

3.  Primary:   Alanine Aminotransferase (ALAT)   [ Time Frame: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)  ]
  Show Outcome Measure 3

4.  Primary:   Bilirubin   [ Time Frame: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit) ]
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5.  Secondary:   D-Dimer   [ Time Frame: 14 weeks according to protocol.(enrolment to week 12 visit)  ]
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6.  Secondary:   Activated Partial Thromboplastin Time (APTT)   [ Time Frame: 12 weeks according to protocol.(baseline to week 12 visit)  ]
  Show Outcome Measure 6

7.  Secondary:   Ecarin Clotting Time (ECT)   [ Time Frame: 12 weeks according to protocol.(baseline to week 12 visit)  ]
  Show Outcome Measure 7

8.  Secondary:   Plasma Concentration of AZD0837 (Prodrug)   [ Time Frame: 12 weeks after baseline according to protocol ]
  Show Outcome Measure 8

9.  Secondary:   Plasma Concentration of AR-H067637XX (Active Metabolite)   [ Time Frame: 12 weeks after baseline according to protocol ]
  Show Outcome Measure 9

10.  Secondary:   Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TT   [ Time Frame: 36 weeks according to protocol ]
  Show Outcome Measure 10

11.  Secondary:   Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TC   [ Time Frame: 36 weeks according to protocol ]
  Show Outcome Measure 11

12.  Secondary:   Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype CC   [ Time Frame: 36 weeks according to protocol ]
  Show Outcome Measure 12


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00684307     History of Changes
Other Study ID Numbers: D1250C00008
Study First Received: May 22, 2008
Results First Received: August 17, 2011
Last Updated: March 20, 2012
Health Authority: Austria: Agency for Health and Food Safety
Denmark: Danish Medicines Agency
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency