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Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT01491178
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Atrial Fibrillation
Intervention: Drug: Prazaxa

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
6772 subjects were enrolled. Among them, Electronic Case Report Form (eCRF) was not collected for 144 subjects and 185 subjects were excluded because of them not following registration rule, no actual visit or previous treatment experience with Prazaxa, leaving 6443 subjects eligible for study who were enrolled and included in the final study.

Reporting Groups
  Description
Patients With NVAF Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d)

Participant Flow:   Overall Study
    Patients With NVAF
STARTED   6443 [1] 
COMPLETED   3649 [2] 
NOT COMPLETED   2794 
Adverse Event                1016 
Improvement of NVAF                210 
To conduct invasive treatment                59 
Lost to follow−up (unknown reason)                287 
Lost to follow−up (changing hospital)                545 
To take a contraindication                20 
Other than specified above                657 
[1] Started are the enrolled subjects who followed registration rule and for who eCRF was collected.
[2] Completed is defined as 104 weeks follow-up after enrollment.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety set: This patient set includes all patients who received treatment of Prazaxa® Capsules except those who were found not following registration rule, no actual visit, previous treatment experience with Prazaxa.

Reporting Groups
  Description
Patients With NVAF Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d)

Baseline Measures
   Patients With NVAF 
Overall Participants Analyzed 
[Units: Participants]
 6443 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.9  (9.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2133  33.1% 
Male      4310  66.9% 


  Outcome Measures

1.  Primary:   Frequency (Percentage) of Participants With Adverse Drug Reactions   [ Time Frame: Up to 104 weeks from first administration of study drug ]

2.  Secondary:   Incidences of Stroke and Systemic Embolism (SEE)   [ Time Frame: Up to 104 weeks from first administration of study drug ]


  Serious Adverse Events


  Other Adverse Events


  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
The study was conducted in an unblinded manner and without controls. The explanatory power of the study results was limited and the study results should be interpreted with the necessary caution.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01491178     History of Changes
Other Study ID Numbers: 1160.130
First Submitted: December 12, 2011
First Posted: December 13, 2011
Results First Submitted: July 26, 2017
Results First Posted: January 30, 2018
Last Update Posted: January 30, 2018