NCT04251039Unknown不适用
"Efficacy and Safety of Oral/iv Therapy (Cangrelor) in Patients With SCAD Undergoing Complex PCI, the RESPONSE Study"
Fondazione GISE Onlus1 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2022年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Safety endpoint: Major bleedings according with Thrombolysis in Myocardial Infarction (TIMI) classification.
研究概览
简要总结
Evaluation of Efficacy/Safety in Cangrelor use in patients with SCAD undergoing complex PCI.
Prospective, observational, multicenter registry.
详细描述
SCAD patients routinely in the Italian centers undergo complex PCIs with pre-treatment with P2Y12 inhibitors or with P2Y12 inhibitors administration after procedure. This implies that participants receive interventions as part of routine medical care, and that researchers actually observe the effect of the intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be at least 65 years of age at the time of signing the Informed Consent Form
- •Patient presenting with SCAD undergoing complex PCI and:
- •Type 2 Diabetes Mellitus;
- •CKD (Grade specified in CRF);
- •Complex SCAD: LMD, 3VD, bifurcation lesions, Rotablator, CTO, multiple Stents, total length of the stents must be greater than 60 mm.
- •Patient is to be treated for de novo lesions located in previously untreated vessels.
- •Patient must agree to undergo all required follow-up visits and data collection.
排除标准
- •History of CABG;
- •In stent restenosis;
- •Patient with intolerance or contra-indications to treatment with aspirin, clopidogrel, prasugrel, ticagrelor, cangrelor, heparin, contrast media;
- •Patient on chronic treatment with oral anticoagulants;
- •Patient with neoplastic or rheumatic diseases;
- •Use of dipyridamole, cilostazol, or anticoagulant therapy during the study period;
- •Bleeding disorder
- •History of an ischemic stroke or intracranial bleeding
- •Intracranial vascular abnormality;
- •Gastrointestinal bleeding within the previous 6 months or major surgery within the previous 30 days.
- •Women who are pregnant/breastfeeding or who have the potential to become pregnant during the study;
- •Patient with bleeding diathesis in whom antiplatelet drug is contraindicated;
- •Concomitant indication to open heart surgery
- •Inability to provide written informed consent
- •Enrolment in another study within 1 month
结局指标
主要结局
Safety endpoint: Major bleedings according with Thrombolysis in Myocardial Infarction (TIMI) classification.
时间窗: hour 48
Number of patients with intracranial hemorrhage or a ≥5 g/dl decrease in hemoglobin concentration or a ≥15 % absolute decrease in hematocrit.
次要结局
- Number of Participants with stent thrombosis(hour 48)
- Time to Coronary Artery Bypass Graft (CABG)(Day 30)
- Efficacy endpoint: Long-term major adverse cardiac and cerebrovascular events MACCE (eg Death from any cause, Any Myocardial infarction, Revascularization, Stroke)(hour 48 and day 30)
- Assessment of platelet reactivity(Day 0)
- Rehospitalisation due to unstable or progressive angina according to the Braunwald Unstable Angina Classification and the Canadian Cardiovascular Society Angina Classification.(Day 30)
研究者
研究点 (1)
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