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 30, 2014
Last verified: July 2014
  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 [ 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:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Korean patients with non-valvular AF

Criteria

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

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

No publications provided

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: July 30, 2014
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
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014