Clinical trial NCT01774370: SPARK: Safety Study of Pradaxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-01-24
Enrollment: 3182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean patients with non-valvular AF

Brief summary: 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.

Detailed description: Study Design:

regulatory Post Marketed Surveillance study

Eligibility criteria: 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

Primary outcomes:
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)
timeFrame: up to 26 weeks
Secondary outcomes:
measure: Percentage of Participants With Stroke
timeFrame: up to 26 weeks
measure: Percentage of Participants With Systemic Embolism
timeFrame: up to 26 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Korea, Republic of
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: