- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02546817
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
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Seoul, 대한민국
- Local Institution
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 전용
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Safety of Eliquis in Korean VTE patients based on incidence of adverse events (AEs), serious adverse events (SAEs)
기간: 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
기간: Approximately 2 years
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Patient Characteristics: Age, sex, weight, height, baseline blood pressure, baseline serum creatinine, baseline creatinine clearance, and device insertion history
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Approximately 2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE
기간: 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
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Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE
기간: 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
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
정맥혈전색전증에 대한 임상 시험
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Beijing Friendship Hospital알려지지 않은대장암 환자에서 Perioperiative Venous Thromboembolism(VTE)의 발생률
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University Hospital, Strasbourg, France완전한
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Medical University Innsbruck완전한급성 신장 손상 | 비판적으로 아프다 | 신장 대체 요법 | 지속적 신대체 요법 | 지속적인 Veno-Venous Hemofiltration | 교체액 | 포실륨 | 비포질 | 항응고제 | 지역 구연산염 항응고제오스트리아