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

NCT01774370 | Completed Results

• 1 other identifier: 1160.139
• Study Type: observational
• Target: 3,182
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Participants With Stroke

  up to 26 weeks

• Percentage of Participants With Systemic Embolism

  up to 26 weeks

Study Arms (1)

Pradaxa group

Drug: Pradaxa (Dabigatran etexilate mesilate)

Interventions

Pradaxa (Dabigatran etexilate mesilate) DRUG

110 mg or 150 mg b.i.d.

Pradaxa group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Korean patients with non-valvular AF

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Unknown Facility

Multiple Locations, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 24, 2013
• Study Start: January 14, 2013
• Primary Completion: February 17, 2017
• Study Completion: February 17, 2017
• Last Updated: March 8, 2019
• Results First Posted: March 8, 2019

Record last verified: 2018-02

Locations

KR (1)