NCT02211066已完成4 期
TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Differences in increase of coronary blood flow (CBF) under adenosine administration from baseline in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group.
研究概览
简要总结
The study is a single-centre, randomized, active controlled, open label clinical trial. The primary hypothesis is that ticagrelor will show superiority over clopidogrel immediately after CTO-PCI (chronic total occlusion - percutaneous coronary intervention)
详细描述
The hypothesis is tested in the first randomization. Both antiplatelet therapy will be used in both arms at the approved doses and for the approved duration therapy of 1-year. The secondary hypothesis will test the role of ticagrelor/clopidogrel alone and together with ABSORB BVS implantation in the recovery of vascular function at long-term. This hypothesis is tested in the second randomization. The angiographic follow-up will be scheduled at 1 or 3-year follow-up in order to test the secondary hypothesis either at the moment of the end of the antiplatelet therapy or at the moment of scaffold bioresorption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients of both sexes, older than 18 years old.
- •Written informed consent obtained.
- •Patients with stable angina pectoris (Canadian Cardiovascular Society (CCS) Class 1, 2, 3 or 4) or patients with documented silent ischemia by stress test during the last year.
- •Patients eligible for coronary revascularization in a coronary chronic total occlusion, which was angiographically documented in a previous coronary angiography during the last year.
排除标准
- •Women who are pregnant or women of childbearing potential who do not use adequate contraception.
- •Known allergies to aspirin, clopidogrel bisulfate (Plavix ®), ticagrelor (BriliqueTM) heparin, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
- •Participation in other studies.
- •Life expectancy of less than one year or factors making clinical and/or angiographic follow-up difficult.
- •Planned cardiac surgery or major non-cardiac surgery.
- •The subject has a history of bleeding diathesis or coagulopathy.
- •The subject suffered disabling stroke within the past year.
- •Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction, which, in the judgment of the Investigator, may affect the patient's ability to complete the study.
- •History of malignancy, except in patients who have been disease-free >5 years or whose only malignancy has been basal or squamous cell skin carcinoma.
- •Inability to provide informed consent
研究组 & 干预措施
Ticagrelor
Experimental
Ticagrelor 90 mg will be administered daily for 1 year
干预措施: Ticagrelor (Drug)
Clopidogrel
Active Comparator
Clopidogrel 75 mg will be administered daily for 1 year
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Differences in increase of coronary blood flow (CBF) under adenosine administration from baseline in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group.
时间窗: Baseline
次要结局
- Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group.(Baseline)
- Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group.(Baseline)
- Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment scaffolded by ABSORB and in that distal to it at 1 year follow-up between the ticagrelor vs. clopidogrel group.(1 year)
- Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment scaffolded by ABSORB and in that distal to it at 3-year follow-up between the ticagrelor vs. clopidogrel group.(3 years)
- Changes from baseline in coronary blood flow after adenosine administration in the coronary segment distal to the scaffold implanted at 3-year follow-up between the ticagrelor vs. clopidogrel group.(3 years)
- Clinical endpoints at 1 and 3 years follow-up: cardiac death, probable or definite scaffold thrombosis, target vessel failure, bleeding.(1 and 3 years)
- Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted at 1-year follow-up between the ticagrelor vs. clopidogrel group.(1 year)
- Changes from baseline in coronary blood flow after adenosine administration in the coronary segment distal to the scaffold implanted at 1-year follow-up between the ticagrelor vs. clopidogrel group(1 year)
- Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted at 3-year follow-up between the ticagrelor vs. clopidogrel group.(3 years)
- Difference in intimal-media thickness at the site of scaffold implanted, evaluated by optical coherence tomography in a subgroup of patients at 1-year follow-up between the ticagrelor vs. clopidogrel group.(1 year)
- Difference in intimal-media thickness at the site of scaffold implanted, evaluated by optical coherence tomography at 3 years follow-up between the ticagrelor vs. clopidogrel group.(3 years)
研究者
Juan A. Arnaiz
Clinical Trial Manager
Hospital Clinic of Barcelona
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
1 期
The use of antiplatelet drug (Ticagrelor) and bioresorbable coronary stent in recovery of vascular function after successful coronary recanalization.EUCTR2013-002675-17-ESFundació Clínic per a la Recerca Biomèdica100
终止
2 期
Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb IschemiaPeripheral Arterial DiseaseNCT02230527The Cleveland Clinic46
已完成
不适用
Reconstruction Techniques and Vascular Approach After Laparoscopic Left Hemicolectomy and Rectum Low Anterior ResectionRectal TumorsColorectal CancerNCT02746224Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta64
已完成
2 期
Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular LymphomaFollicular LymphomaNCT03568461Novartis Pharmaceuticals98
已完成
3 期
TOSCARA Study: A Study of Subcutaneous Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis Naïve to RoActemra/Actemra TreatmentRheumatoid ArthritisNCT02031471Hoffmann-La Roche57