Optimal duration of dual antiplatelet therapy in patients treated by endovascular revascularization of the superficial femoral artery (Dual Antiplatelet Therapy-Superficial Femoral Artery, DAPT-SFA) - Optimal duration of dual anti-platelet therapy in patients undergoing endovascular revascularization

FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO0 个研究点目标入组 78 人开始时间: 2020年11月4日最近更新: 2021年1月5日

适应症

试验速览

暂无简介。

•Have given written informed consent to participate
•Be aged 18 years and over
•Be affected by lower limbs PAOD staged 2-5 according to Rutherford classification and lesions of the SFA
•Have undergone a successful endovascular revascularization of the SFA as documented by the intra-operative angiography
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 48

•-Life expectancy < 12 months
•-Contraindication to DAPT or ASA/clopidogrel assumption (Hypersensitivity to the basic principle or excipients, history of acute asthma or angioneurotic edema associated with drug assumption, peptic ulcer and/or gastro-intestinal haemorrhage in acute phase or in medical records, or other kinds of haemorrhage (e.g. cerebrovascular bleeding), haemorrhagic diathesis, haemostasis disturbances (e.g. Thrombocytopenia or haemophilia), severe cardiac failure, severe liver failure, severe CKF (GFR<30ml/h), therapy with methotrexate at dosage > 15 mg per week)
•-Participants to a clinical trial consisting in administration of an experimental drug within 30 days or 5 half-lives of the drug under investigation.
•-Patients under anticoagulant therapy
•-History of allergies to ASA and/or clopidogrel
•-Lack of written informed consent by the patients
•-Unwillingness, impossibility or incapability to respect the study protocol for any reason
•-CKF under haemodialytic treatment, because it can affect the patency rate of the lumen bias the results on such a small-sized sample)
•-Pregnant women

发起方

FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO