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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
  Purpose
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.

Condition Intervention
Atrial Fibrillation
Drug: Pradaxa (Dabigatran etexilate mesilate)

Study Type: Observational
Study Design: Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 3000
Study Start Date: January 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pradaxa group Drug: Pradaxa (Dabigatran etexilate mesilate)
110 mg or 150 mg b.i.d.

Detailed Description:

Study Design:

regulatory PMS study

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Korean patients with non-valvular AF
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774370

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Show 82 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01774370     History of Changes
Other Study ID Numbers: 1160.139 
Study First Received: January 16, 2013
Last Updated: September 15, 2016
Health Authority: South Korea: Ministry of Food and Drug Safety (MFDS)

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants

ClinicalTrials.gov processed this record on September 27, 2016