N/A
Completed N=3,182
SPARK: Safety Study of Pradaxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea
Source: ClinicalTrials.gov NCT01774370 ↗Enrolled (actual)
3,182
Serious AEs
3.4%
Results posted
Mar 2019
Primary outcomePrimary: 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) — 871 Adverse events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
871 | — |
| SECONDARY Percentage of Participants With Stroke |
0.30; 99.70 | — |
| SECONDARY Percentage of Participants With Systemic Embolism |
100.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01774370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.