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

Atrial Fibrillation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774370
• Other study ID #: 1160.139
• Status: Completed
• Start date: January 14, 2013
• Est. completion date: February 17, 2017

Study information

• Verified date: February 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Study Design:

regulatory Post Marketed Surveillance study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3182
• Est. completion date: February 17, 2017
• Est. primary completion date: February 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Pradaxa (Dabigatran etexilate mesilate)
110 mg or 150 mg b.i.d.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

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