PRotective Effect on the Coronary Microcirculation of Patients With DIabetes by Clopidogrel or Ticagrelor
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Delta IMR post-PCI
研究概览
简要总结
The purpose of this study is to determine whether Ticagrelor has a protective effect on microcirculation during percutaneous coronary interventions in patients with Diabetes mellitus type II or in a pre-diabetic status.
详细描述
Introduction:
Patients with Diabetes Mellitus (DM) Type 2 still consistently perform worse than their non-diabetic counterparts especially in the setting of Percutaneous Coronary Intervention (PCI). The abnormal coronary microcirculation along with the higher risk of distal embolization of particles released from the PCI target lesion constitutes the main cause of peri-procedural microcirculatory damage.
New antiplatelet agents, in particular Ticagrelor, might also play a protective role on microcirculation. Ticagrelor inhibits cellular uptake of adenosine, increasing the circulating levels of adenosine through the inhibition of its physiological clearance. Adenosine may protect the myocardium from both ischemic, and reperfusion injury via its potent vasodilatory effects and possibly by anti-inflammatory and antiplatelet properties.
Additionally previous research have identified a more profound effect of adenosine on microcirculatory resistance associated to obesity and diabetes and a higher myocardial protective effect of Ticagrelor during PCI might be expected in this high risk subgroup of patients.
The purpose of PRotective Effect on the Coronary Microcirculation of Patients With DIabetes by Clopidogrel or Ticagrelor (PREDICT) trial was designed to investigate the protective effect of Ticagrelor on microcirculation during PCI in stable diabetic patient
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
- •Subject with Diabetes Mellitus (DM) Type II
- •Subject must be older than 18 years
- •Written informed consent available
- •Subject with stable ischemic heart disease referred for coronary angiography
- •Subject is eligible for PCI, and PCI target(s) have FFR≤0.80
排除标准
- •Prior myocardial infarction in the territory of the target vessel
- •Akinesia or dyskinesia in subtended myocardial segments
- •Severe impairment of left ventricular function (LVEF) <35%
- •PCI target is a chronic total occlusion
- •Target lesion has been treated previously (restenotic lesions)
- •Target vessel is a saphenous vein graft or a surgical graft has been anastomosed to target vessel
- •Thrombolisis in Myocardial Infarction (TIMI) flow ≤ 1 prior to guide wire crossing
- •Subject is not eligible for treatment with DES
- •Bleeding disorders or chronic anticoagulant treatment
- •Left main stenosis > 50%
- •Coronary surgery deemed more beneficial for the patient than PCI
- •Intolerance or contraindications to anti-platelet drugs
- •Contraindications for adenosine administration
- •Platelet count <75000 or >700000/mm3
- •Immunosuppressive therapy
- •Pregnant or breast feeding patient
- •History of intracranial haemorrhage
- •Severe hepatic impairment
研究组 & 干预措施
Ticagrelor
A loading dose of Ticagrelor 180mg followed by a dose of 90mg b.i.d. (during 48 hours)
干预措施: Diagnostic (Procedure)
Ticagrelor
A loading dose of Ticagrelor 180mg followed by a dose of 90mg b.i.d. (during 48 hours)
干预措施: Randomization (Drug)
Ticagrelor
A loading dose of Ticagrelor 180mg followed by a dose of 90mg b.i.d. (during 48 hours)
干预措施: PCI (Procedure)
Clopidogrel
A loading dose of Clopidogrel 600mg followed by a daily dose (during at least 48 hours) of 75mg
干预措施: Diagnostic (Procedure)
Clopidogrel
A loading dose of Clopidogrel 600mg followed by a daily dose (during at least 48 hours) of 75mg
干预措施: Randomization (Drug)
Clopidogrel
A loading dose of Clopidogrel 600mg followed by a daily dose (during at least 48 hours) of 75mg
干预措施: PCI (Procedure)
结局指标
主要结局
Delta IMR post-PCI
时间窗: at least 48 hours after randomization, just after PCI and stenting.
Absolute difference in the IMR value associated to PCI \["Delta IMR Post-PCI" = (IMR value post-PCI) minus (IMR value pre-PCI)\]
Delta IMR pre-PCI
时间窗: at least 48 hours after randomization, just before PCI and stenting.
Absolute difference in the IMR value associated to PCI \["Delta IMR Pre-PCI" = (IMR value pre-PCI) minus (IMR value at baseline)\]
次要结局
- Myocardial necrosis associated to PCI damage(at least 72 hours, at the time of hospital discharge.)
- Severe microcirculatory impairment(at least 48 hours after randomization, just after PCI and stenting.)
- IMR post-PCI(at least 48 hours after randomization, just after PCI and stenting.)
研究者
Javier Escaned
Unit head
Hospital San Carlos, Madrid