EUCTR2017-002340-32-IT进行中（未招募）1 期
APIDULCIS: Extended anticoagulation with low-dose apixaban after a standard course anticoagulation in patients with a first venous thromboembolism who have positive d-dimer - APIDULCIS
FONDAZIONE ARIANNA ANTICOAGULAZIONE0 个研究点目标入组 1,200 人开始时间: 2020年11月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- outpatients with a single episode of venous thromboembolism (VTE), at a first episode of proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE),
- •- unprovoked VTE or associated with weak risk factors for thrombosis
- •- Age older than 18 or younger than 75 years
- •- Capacity to give written informed consent
- •- Males and females of any ethnic group
- •- 12 months of previous anticoagulant therapy (with any anticoagulant drug)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
排除标准
- •1) Events usually associated with low risk of recurrence
- •DVT/PE occurred within 3 months from major surgery or major trauma
- •Isolated Distal DVT (thrombosis of calf veins)
- •2) Events associated with a very high risk of recurrence or occurrence of life-threatening recurrent events
- •PE episode with shock or life-threatening
- •Isolated PE with a systolic pulmonary artery pressure > 60 mmHg at presentation
- •DVT/PE associated with active cancer, antiphospholipid syndrome or long-standing medical illnesses
- •More than one idiopathic event
- •3) Index VTE events not included in the study
- •All VTE events that occurred in different sites than deep veins of the lower limbs or pulmonary arteries
- •Age younger than 18 or older than 75 years
- •More documented unprovoked VTE episodes
- •Pregnancy or puerperium
- •Severe post-thrombotic syndrome (=> 15 points at the Villalta score)
- •Solid neoplasia or blood disease in active phase or requiring chemotherapy/radiotherapy
- •All the clinical conditions requiring prolonged treatment with LMWH
- •Presence of overt, active chronic diseases (i.e. inflammatory bowel disease)
- •Known serious thrombophilic alterations:
- •Any absolute contraindication to anticoagulant therapy
- •Any contraindication to apixaban (as per local SmPC)
- •Presence of antiphospolipid syndrome
- •Presence of cava filter
- •Concomitant conditions (such as atrial fibrillation) requiring indefinite anticoagulation
- •Severe cardio-respiratory insufficiency (NYHA 3 or 4)
- •Life expectancy shorter than 1 year
- •Refuse interruption of anticoagulation to perform serial D-dimer assessment
- •Geographically inaccessible location
- •Inability or refusal to give consent
- •Concomitant enrollment in other non observational study
研究者
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