MULTIcentric Study About RESistance to CLOpidogrel in Dual Antiplatelet Therapy for Carotid Stenting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,140
- 试验地点
- 1
- 主要终点
- MACE
研究概览
简要总结
Spontaneous prospective observational multicentre pharmacological study that aims to evaluate whether, from a statistical point of view, there is a significant difference between the use of Ticagrelor in "non-responders" patients to Clopidogrel undergoing carotid stenting and Clopidogrel in "responders" undergoing carotid stenting, in the onset of death and major adverse cardiovascular events (MACE) and bleeding events, 1 and 3 months after the procedure. Furthermore, the study aims to evaluate the possible preoperative clinical and pharmacological factors most associated with the phenomenon of resistance to Clopidogrel.
Inclusion criteria:
The data will be collected on adult patients (age> 18 years) who have given their consent to participate in the study, belonging to the U.O. of Vascular Surgery of the IRCCS Policlinico San Donato and the U.O. of Vascular Surgery of the participating centers and there subjected to the treatment of carotid stenosis by stenting technique.
Exclusion criteria:
Those patients who are minors, who have not given their consent to participate in the study, or who have carotid stenosis not susceptible to intervention by stenting will be excluded from the study. Pregnant or lactating women will also be excluded from the study (such as situations in which carotid stenting is contraindicated regardless of the execution of the study).
详细描述
Patients' records will be reviewed for clinical data (age, sex, height and weight), the presence of cardiovascular risk factors (diabetes mellitus, hypertension, dyslipidemia, smoking habits, coronary artery disease, chronic obstructive pulmonary disease), features of the carotid plaque (type of plaque and degree of carotid stenosis, according to ECST measurement), and status of the contralateral carotid artery. The occurrence of preoperative neurologic symptoms within the previous 6 months will also be recorded, as evaluated by the neurologist.
Preoperative and postoperative drug intake will be investigated, with particular attention to statins, beta blockers, angiotensin-converting enzyme (ACE) inhibitors, antiplatelet therapy and anticoagulant therapy.
Laboratory data such as serum creatinine, platelet counts, Red blood cell Distribution Width (RDW), Prothrombin Time (PT), International Normalized Ratio (INR), activated Partial Thromboplastin Time (aPTT) and ratio will be also assessed.
After operation, patients will be followed up three times in the first year (at 1 month, 6 months, and 12 months) and annually thereafter, using ultrasound. An angio-Computed Tomography scan will be required when complications were detected at ultrasound examination. During follow-up, data will be collected about the occurrence of death, stent thrombosis, cerebrovascular events, cardiac events, major haemorrhagic events.
Determination of the effectiveness of antiplatelet drugs The effectiveness of antiplatelet drugs will be evaluated through the impedance aggregometry test, conducted with the Multiplate® platelet function analysis V2.03.11 (Roche, Basel, Switzerland).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients (age> 18 years)
- •patients who have given their consent to participate in the study, belonging to the U.O. of Vascular Surgery of the IRCCS Policlinico San Donato and the U.O. of Vascular Surgery of the participating centers and subjected to the treatment of carotid stenosis by stenting technique.
排除标准
- •underage patients
- •patients who have not given their consent to participate in the study,
- •patients who have carotid stenosis not susceptible to intervention by stenting
- •pregnant or lactating women (such as situations in which carotid stenting is contraindicated regardless of the execution of the study).
研究组 & 干预措施
Clopidogrel
Patients who undergo carotid stenting and dual antiplatelet therapy with ASA + clopidogrel and whose aggregometry test shows correct response to the effect of clopidogrel
干预措施: Clopidogrel (Drug)
Ticagrelor
Patients who undergo carotid stenting and dual antiplatelet therapy with ASA + clopidogrel and whose aggregometry test shows incorrect response to the effect of clopidogrel, therefore therapy is switched to ASA + ticagrelor
干预措施: Ticagrelor (Drug)
结局指标
主要结局
MACE
时间窗: 3 months
Major Adverse Cardiovascular Events, Outpatient visit
Death
时间窗: 3 months
Outpatient visit
Occurrence of major hemorrhagic events
时间窗: 3 months
Outpatient visit
Death
时间窗: 1 month
Outpatient visit
MACE
时间窗: 1 month
Major Adverse Cardiovascular Events, Outpatient visit
Occurrence of major hemorrhagic events
时间窗: 1 month
Outpatient visit
次要结局
未报告次要终点
研究者
Daniela Mazzaccaro
Principal Investigator
IRCCS Policlinico S. Donato