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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 September 2016 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01774370
First received: January 16, 2013
Last updated: September 15, 2016
Last verified: September 2016

January 16, 2013
September 15, 2016
January 2013
December 2016   (final data collection date for primary outcome measure)
Occurrence of adverse events(Including unexpected adverse events, serious adverse events, drug-related adverse events, adverse events leading to discontinuation and adverse events by intensity, outcome of the event, causality) [ 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 ]
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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:

  • Age >= 18 years at enrollment
  • Patients who have been started on Pradaxa in accordance with the approved label in Korea
  • Patients who have signed on the data release consent form

Exclusion criteria:

  • Patients with previous exposure to Pradaxa
  • Clinically significant bleeding
  • Increased risk of bleeding due to following diseases;

    • Recent gastrointestinal ulceration
    • Recent intracranial or intracerebral bleeding history
    • Intraspinal or intracerebral vascular abnormalities
    • Recent brain, spinal or ophthalmic surgery
    • Recent brain or spinal injury
    • Known or suspected oesophageal varices
    • Arteriovenous malformations
    • Vascular aneurysms
    • Presence of malignant neoplasms at high risk of bleeding
  • Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under the circumstances of switching therapy to or from Pradaxa or when UFH is given at doses necessary to maintain an open central venous or arterial catheter
  • Severe renal impairment (CrCl < 30mL/min)
  • Concomitant treatment with oral ketoconazole or dronedarone
  • Patients hypersensitive to dabigatran or dabigatran etexilate or to any ingredient in the formulation
  • Prosthetic heart valve replacement
  • No creatinine clearance collected within at least one year prior to enrollment
  • Current participation in other clinical trials
Both
18 Years and older   (Adult, Senior)
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Korea, Republic of
 
NCT01774370
1160.139
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
September 2016

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