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Eliquis (VTE Treatment and Prevention of Recurrent VTE) rPMS
Eliquis (Apixaban) Regulatory Postmarketing Surveillance In Real World Practice (rPMS) For Venous Thromboembolism (VTE) Treatment And Prevention Of Recurrent VTE
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Seoul, Korea, republiek van
- Local Institution
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Adult (≥19 years of age) patients who are initiating treatment with Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time in accordance with the Korean package insert will be enrolled in the study
Exclusion Criteria:
- Patients with prior treatment with Eliquis before enrollment in this study
- Patients receiving Eliquis treatment for an indication not approved indication in Korea
Patients meeting any of the following criteria will not be included in the study:
i) Hypersensitivity to the active substance or to any of the excipients
ii) Clinically significant active bleeding
iii) Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
iv) Patients with increased bleeding risk due to such as following diseases:
- Recent gastrointestinal ulceration history
- Recent intracranial or intracerebral haemorrhage history
- Intraspinal or intracerebral vascular abnormalities
- Recent brain, spinal or ophthalmic surgery history
- Recent brain or spinal injury
- Known or suspected oesophageal varices
- Arteriovenous malformations
- Vascular aneurysms
Patients with malignant neoplasms at high risk of bleeding
- Concomitant treatment with any other anticoagulant agent:
i) Unfractionated heparin (UFH)
ii) Low molecular weight heparins (enoxaparin, dalteparin, etc)
iii) Heparin derivatives (fondaparinux, etc)
iv) oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc) except under the circumstances of switching therapy to or from apixaban or when UFH is given at doses necessary to maintain a patent central venous or arterial catheter
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Case-Alleen
- Tijdsperspectieven: Prospectief
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Safety of Eliquis in Korean VTE patients based on incidence of adverse events (AEs), serious adverse events (SAEs)
Tijdsspanne: Approximately 2 years
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Approximately 2 years
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Patient characteristics that are associated with bleeding among patients taking Eliquis
Tijdsspanne: Approximately 2 years
|
Patient Characteristics: Age, sex, weight, height, baseline blood pressure, baseline serum creatinine, baseline creatinine clearance, and device insertion history
|
Approximately 2 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE
Tijdsspanne: Approximately 2 years
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For VTE treatment: The proportion of patients with recurrent VTE at 24 weeks will be calculated. The incidence proportion will be estimated For prevention of recurrent VTE: The proportion of patients with recurrent VTE at 24 weeks, 52 weeks, and 104 weeks, will be calculated. The incidence proportion will be estimated |
Approximately 2 years
|
Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE
Tijdsspanne: Approximately 2 years
|
For VTE treatment: The proportion of patients with recurrent VTE at 24 weeks will be calculated. The 95% confidence intervals will be estimated For prevention of recurrent VTE: The proportion of patients with recurrent VTE at 24 weeks, 52 weeks, and 104 weeks, will be calculated. The 95% confidence intervals will be estimated |
Approximately 2 years
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CV185-440
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