SPARK: Safety Study of Pradaxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01774370
First received: January 16, 2013
Last updated: July 23, 2014
Last verified: July 2014

January 16, 2013
July 23, 2014
January 2013
December 2016   (final data collection date for primary outcome measure)
Occurrence of adverse events [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
Adverse events reported after intake of Pradaxa [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01774370 on ClinicalTrials.gov Archive Site
  • Incidence rate of stroke [ Time Frame: up to 26 weeks ] [ Designated as safety issue: Yes ]
  • Incidence rate of systemic embolism [ Time Frame: up to 26 weeks ] [ Designated as safety issue: Yes ]
Incidence rate of stroke and systemic embolism [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
SPARK: Safety Study of Pradaxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea
A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Pradaxa (Dabigatran Etexilate Mesilate, 110 mg or 150 mg b.i.d.) in Korean Patients With Non-valvular Atrial Fibrillation(SPARK: Safety Study of Pradaxa in AF Patients by Regulatory Requirement of Korea)

This is a prospective, non-interventional, open-label, multi-centre study. It will provide additional safety information of Pradaxa in Korean patients with non-valvular AF in clinical settings.

Study Design:

regulatory PMS study

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Korean patients with non-valvular AF

Atrial Fibrillation
Drug: Pradaxa (Dabigatran etexilate mesilate)
110 mg or 150 mg b.i.d.
Pradaxa group
Intervention: Drug: Pradaxa (Dabigatran etexilate mesilate)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
February 2017
December 2016   (final data collection date for primary outcome measure)

Inclusion criteria:

Patients who have been started on Pradaxa in accordance with the approved label in Korea

Exclusion criteria:

Patient with previous experience to Pradaxa Current participation in other clinical trials or registries

Both
19 Years and older
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Korea, Republic of
 
NCT01774370
1160.139
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP