APIDULCIS: Extended Anticoagulation With Low-dose Apixaban After a Standard Course Anticoagulation in Patients With a First Venous Thromboembolism Who Have Positive D-dimer
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Number and rate of patients with confirmed recurrent VTE and VTE-related death (efficacy).
研究概览
简要总结
The study aims at optimizing the long-term and extended management of patients with a first episode of venous thromboembolism (proximal deep vein thrombosis with or without pulmonary embolism) (VTE). Patients at high risk of recurrence (with altered D-dimer test), who had received anticoagulation (whatever the drug used) for 12-15 months after the first episode of thrombosis, will be treated with Apixaban 2,5 mg x 2 for 18 months as extended treatment. Patients at low risk, with normal D-dimer test, will stop anticoagulation definitely.
详细描述
This prospective cohort study aims to assess the efficacy and safety of a management procedure to decide on giving or not an extended anticoagulation (administering apixaban 2 2.5 mg twice daily ) to outpatients with a single episode of proximal deep vein thrombosis of the lower limbs and/or pulmonary embolism who had received 12-15 months of anticoagulation (whatever the anticoagulant drug used). The study seeks to assess whether a management procedure involving D-dimer testing assessment can identify a subset of subjects at low risk of recurrence in whom an extended anticoagulation can be safely avoided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First unprovoked Venous Thromboembolic Event
- •Venous Thromboembolic events associated with one or more risk factors that are no longer present
- •Age older than 18 or younger than 75 years
- •Capacity to give written informed consent
排除标准
- •A) Exclusion criteria regarding the index event
- •Events usually associated with low risk of recurrence
- •Deep vein thrombosis/ Pulmonary embolism occurred within 3 months from major surgery or major trauma
- •Isolated Distal deep vein thrombosis (thrombosis of calf veins)
- •Events associated with a very high risk of recurrence or occurrence of life-threatening recurrent events
- •Pulmonary Embolism episode with shock or life-threatening
- •Isolated pulmonary embolism with a systolic pulmonary artery pressure > 60 mmHg at presentation
- •Deep vein thrombosis/ Pulmonary embolism associated with active cancer, antiphospholipid syndrome or long-standing medical illnesses
- •More than one idiopathic event
- •Index venous thromboembolic event in different sites than deep veins of the lower limbs or pulmonary arteries
- •B) Exclusion criteria present at the moment of patients' screening:
- •Age younger than 18 or older than 75 years
- •More documented unprovoked venous thromboembolic 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 Low Molecular Weight Heparin
- •Presence of overt, active chronic diseases (i.e. inflammatory bowel disease)
- •Known serious thrombophilic alterations:
- •deficiencies of natural anticoagulants (Antithrombin, Protein C, Protein S)
- •homozygosity for Factor V Leiden or Factor II G20210A mutations
- •double heterozygosity
- •Presence of antiphospholipid syndrome
- •Presence of vein cava filter
- •Concomitant conditions (such as atrial fibrillation) requiring indefinite anticoagulation
- •Severe cardio-respiratory insufficiency (NYHA 3 or 4)
- •Any absolute contraindications to anticoagulation treatment
- •Any other contraindications to Apixaban as per local SmPC
- •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
研究组 & 干预措施
Positive D-Dimer
At the first positive D-dimer results (during anticoagulation or after its temporary withdrawal) the patients are invited to assume Eliquis (apixaban) 2.5 mg twice daily, and continue this therapy for the following 18 months.
干预措施: Apixaban (Drug)
结局指标
主要结局
Number and rate of patients with confirmed recurrent VTE and VTE-related death (efficacy).
时间窗: From date of enrollment until the date of first documented event assessed up to 18 months
The occurrence of proximal deep vein thrombosis with or without pulmonary embolism (new or recurrent episode) wil be recorded in all patients
Number and rate of major Bleeding events (defined according to International Society on Thrombosis and Haemostasis guidelines (safety)
时间窗: From date of enrollment until the date of first documented event assessed up to18 months
Fatal bleeding; intracranial; intraspinal; intraocular; pericardial; intra-articular; intramuscular with compartment syndrome; retroperitoneal,; acute clinically overt bleeding will be recorded in all patients
次要结局
- Number and rate of non major bleeding complications(From date of enrollment until the date of first documented event assessed up to18 months)
- Number of and rate of thromboembolic events(From date of enrollment until the date of first documented event assessed up to 18 months)
- Presence of severe post-thrombotic syndrome according to Villalta Score(18 months)
- Number and rate of dead patients (overall mortality)(From date of enrollment until the date of first documented event assessed up to 18 months)