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

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)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Pradaxa (Dabigatran etexilate mesilate)

Detailed Description

Study Design:

regulatory Post Marketed Surveillance study

• Study Type: Observational
• Enrollment (Actual): 3182

Contacts and Locations

Study Locations

• Korea, Republic of
  • Multiple Locations, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Korean patients with non-valvular AF

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pradaxa group	Drug: Pradaxa (Dabigatran etexilate mesilate); 110 mg or 150 mg b.i.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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). Number analyzed presents the "Number of participants with Adverse events"	up to 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Stroke	Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction.	up to 26 weeks
Percentage of Participants With Systemic Embolism	Systemic embolism was defined as an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and was to be documented by angiography, surgery, scintigraphy or autopsy.	up to 26 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2013
• Primary Completion (ACTUAL): February 17, 2017
• Study Completion (ACTUAL): February 17, 2017

Study Registration Dates

• First Submitted: January 16, 2013
• First Submitted That Met QC Criteria: January 21, 2013
• First Posted (ESTIMATE): January 24, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2019
• Last Update Submitted That Met QC Criteria: November 10, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Dabigatran
• Other Study ID Numbers: 1160.139