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

NCT ID: NCT01774370

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3182 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-14
• Study Completion Date: 2017-02-17

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

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Pradaxa group

Pradaxa (Dabigatran etexilate mesilate)

Intervention Type: DRUG

110 mg or 150 mg b.i.d.

Interventions

Pradaxa (Dabigatran etexilate mesilate)

110 mg or 150 mg b.i.d.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Multiple Locations, , South Korea

Countries

South Korea

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1160.139

Identifier Type: -

Identifier Source: org_study_id