PRotective Effect on the coronary microcirculation of patients with DIabetes by Clopidogrel or Ticagrelor:A randomized multicenter clinical trial using intracoronary multimodal physiology - PREDICT

Fundación Interhospitalaria de Investigación Cardiovascular0 个研究点目标入组 50 人开始时间: 2016年2月3日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•? Subject with Diabetes Mellitus Type II or pre-Diabetes Mellitus Type II status.
•? 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.
•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 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 35

•? 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.
•? 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.

发起方

Fundación Interhospitalaria de Investigación Cardiovascular