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

Boehringer Ingelheim

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Pradaxa (Dabigatran etexilate mesilate)

Study type: Observational

Funder types: Industry

Identifiers

NCT01774370

1160.139

Details and patient eligibility

About

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.

Full description

Study Design:

regulatory Post Marketed Surveillance study

Enrollment: 3,182 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,182 participants in 1 patient group

Pradaxa group

Treatment:

Drug: Pradaxa (Dabigatran etexilate mesilate)