NL-OMON54840招募中3 期
ong-term treatment of cancer associated venous thromboembolism: reduced vs full dose of apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis - API-CAT
Assistance Publique-Hôpitaux de Paris (APHP) delegated to Recherche Clinique et à lInnovation (DRCI)0 个研究点目标入组 110 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Signed Written Informed Consent
- •Any cancer diagnosed histologically (other than basal-cell or squamous-cell
- •carcinoma of the skin, primary brain tumor or intra-cerebral metastasis)
- •Active cancer defined as the presence of measurable disease or ongoing (or
- •planned) chemotherapy, radiotherapy, hormonotherapy, targeted therapy,
- •immunotherapy at inclusion.
- •Objectively documented index event of :
- •symptomatic or incidental proximal lower-limb, iliac, inferior vena cava
- •DVT or symptomatic or incidental PE in a segmental or larger pulmonary artery
- •(1) Proximal DVT is defined as DVT that involves at least the popliteal vein or
- •a more proximal vein, demonstrated by imaging with compression ultrasound
- •(CUS), including grey-scale or color-coded Doppler, or ascending contrast
- •venography or contrast enhanced computed tomography or magnetic resonance
- •(2) PE has to be demonstrated by imaging as follows:
- •* an intraluminal filling defect in segmental or more proximal branches on
- •contrast enhanced chest computed tomography or on computed tomography pulmonary
- •angiography ; or
- •* an intraluminal filling defect or a sudden cutoff of vessels more than 2.5 mm
- •in diameter on the pulmonary angiogram; or
- •* a perfusion defect of at least 75% of a segment with a local normal
- •ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)
- •(3) Incidental VTE is defined as proximal DVT or PE detected by imaging
- •incidentally when a patient undergoes imaging studies as standard of care for
- •the management of his or her malignancy or other reasons but not for a VTE
- •suspicion(e.g. cancer diagnosis or staging).• At least 6 months of
- •anticoagulant therapy at therapeutic dosage (whatever the drug and the dosing),
- •or completed assigned clinical trial study treatment, for the treatment of the
- •index event; and patient still receiving anticoagulant treatment after
- •occurrence or the index VTE .
- •No objectively documented symptomatic recurrence of VTE between the index
- •event and randomization.
排除标准
- •WOCBP who are unwilling or unable to use an acceptable method of birth
- •control [such as oral contraceptives, other hormonal contraceptives (vaginal
- •products, skin patches, or implanted or injectable products), or mechanical
- •products such as an intrauterine device or barrier methods (condoms)] to avoid
- •pregnancy for the entire study • Women who are pregnant or breastfeeding •
- •Women with a positive pregnancy test on enrollment or prior to investigational
- •product administration • Isolated sub-segmental (incidental or symptomatic) PE
- •without associated DVT • Isolated distal DVT of the legs • Isolated
- •upper-extremity DVT or superior vena cava thrombosis • Isolated visceral
- •thrombosis • Isolated catheter thrombosis • Objectively documented symptomatic
- •recurrence of VTE after the index event under anticoagulant treatment • VTE
- •during anticoagulant treatment given at therapeutic dosage • Subjects with
- •indications for long-term treatment with a VKA, such as: - Mechanical heart
- •valve - Antiphospholipid syndrome • Subjects with indication for long-term
- •anticoagulation with a VKA or a DOAC at therapeutic dosage • Conditions
- •increasing the risk of serious bleeding - intracranial or intraocular bleeding
- •within the 6 months - major surgery within 2 weeks prior to randomization -
- •overt major bleeding at time of randomization • Life expectancy < 12 months
- •Eastern Cooperative Oncology Group (ECOG) level 3 or 4 • Bacterial
- •endocarditis • Uncontrolled hypertension: systolic blood pressure >180 mm Hg
- •or diastolic blood pressure >110 mm Hg • Platelet count < 75,000/mm3 •
- •Hemoglobin < 8g /dl • Creatinine clearance < 30 ml /min based on the
- •Cockcroft Gault equation (see Section 5.7.4) • Acute hepatitis, chronic active
- •hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or
- •more and/or bilirubin level 2 times or more higher the upper limit of the
- •normal range • Subjects requiring ASA >165 mg/day at randomization or
- •thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) • Subjects
- •requiring dual anti-platelet therapy (such as acetylsalicylic acid plus
- •clopidogrel or acetylsalicylic acid plus ticlopidine) at randomization.
- •Subjects who transition from dual antiplatelet therapy to monotherapy prior to
- •randomization will be eligible for the trial • Concomitant use of strong
- •inhibitors of both cytochrome P-450 3A4 and P Glycoprotein (e.g. human
- •immunodeficiency virus protease inhibitors or systemic ketoconazole) or strong
- •inducers of both cytochrome P-450 3A4 and P Glycoprotein (e.g. rifampicin,
- •carbamazepine, or phenytoin) • Prisoners or subjects who are involuntarily
- •incarcerated • Subjects who are compulsorily detained for treatment of either a
- •psychiatric or physical (e.g. infectious disease) illness • Hypersensitivity to
- •apixaban • Subjects participating in another pharmaco therapeutic program with
- •an experimental therapy that is known to affect the coagulation system • Under
- •18 years old • Patients under legal protection (guardianship; court decision)
研究者
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