EUCTR2019-000570-33-IT进行中（未招募）1 期
The Jason study: Sulodexide (VESSEL®) for the prevention of recurrent venous thromboembolism in elderly patients after a first episode of venous thrombembolism (VTE) - The Jason Study
FONDAZIONE ARIANNA ANTICOAGULAZIONE0 个研究点目标入组 1,455 人开始时间: 2021年6月17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
- 1,455
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
- •1)Patients with a first event of proximal lower extremity DVT and / or PE, idiopathic or associated with weak or removed risk factors.
- •2)Patients aged =75 years at the time of enrolment
- •3)Pazienti with at lesast one of the known risk factors of bleeding (APPENDIX 1):
- •a.Hypertension
- •b.Renal failure
- •c.Thrombocytopenia
- •e.Antiplatelet therapy (ASA maximum 140 mg/die)
- •f.Frequent falls (>2 /years)
- •g.Nonsteroidal anti-inflammatory drug
- •h.Liver failure
- •i.Previous Stroke
- •k.Poor anticoagulant control
- •l.Alcohol abuse
- •4)Patients of both sexes.
- •5)Patients who at the time of enrolment have already undergone a period of anticoagulant therapy (AT, with any medication) of at least 3 months and the therapy has not been suspended for more than 30 days.
- •6)Patients with no other AT indications.
- •7)Patients capable and able to provide informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1455
排除标准
- •1)Patients aged <75 years at the time of the recruitment visit.
- •2)Provoked index event, which occurred:
- •Within 3 months of surgery or major trauma (general anesthesia> 30 min)
- •Relapse > 4 days,
- •Cast / immobilization within 3 months.
- •3)Index event represented by severe PE, with life threatening risk or which involved thrombolytic therapy.
- •4)Index event represented by isolated distal DVT or superficial venous thrombosis.
- •5)Thrombotic event that involved sites other than the deep proximal veins of the lower limbs.
- •6)Anticoagulant therapy in progress for less than 3 months at the time of enrolment.
- •7)Discontinuation of anticoagulant therapy for over three months
- •8)Recurrent episodes of DVT ± PE.
- •9)Presence of severe post-thrombotic syndrome (Villalta score >15 or presence ofvenous ulcer).
- •10)Presence of other clinical conditions requiring anticoagulant therapy.
- •11)Active cancer.
- •12)Presence of Inferior vena cava (IVC) filter.
- •13)Known bleeding diatheses.
- •14)Patients in therapy with antiplatelet medicinal products other than ASA. The ASA is allowed up to 140 mg / day.
- •15)All clinical conditions requiring long-term treatment with low molecular weight heparin (LMWH).
- •16)Presence of Antiphospholipid Antibody Syndrome (according to Sydney criteria)
- •17)Known carriers of one or more of the following thrombophilic alterations: deficiency of physiological anticoagulants (antithrombin, protein C, protein S).
- •18)Presence of chronic diseases in acute or active phase (e.g.: inflammatory bowel disease)
- •19)Cardiorespiratory failure (New York Heart Association class 3 or 4).
- •20)Patients incapacitated or refusing to sign the informed consent.
- •21)Patients with life expectancy under 1 year.
- •22)Patients residing in a disadvantaged geographical area.
- •23)Patient already enrolled in other clinical trials.
- •24)Patients with systolic pulmonary artery pressure > 40 mm hg (upper limit for elderly).
- •25)Contraindication to Sulodexide (VESSEL®) and Placebo
研究者
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