CYCLosporinE A in reperfused acute myocardial infarction (CYCLE-Trial) - CYCLE

IST. DI RICERCHE FARMACOLOG. M. NEGRI0 个研究点目标入组 444 人开始时间: 2011年9月6日最近更新: 2015年10月19日

试验速览

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•All (male and female) patients, aged over 18, presenting with a large STEMI within 4 hours of onset (defined as angina pectoris or equivalent symptoms of more than 20 minutes duration within the last 4 hours and ST elevation in = 3 leads in anterior MI and/or a deviation in = 4 leads in inferior MI, with a TIMI-flow 0 or 1 in the culprit artery, committed to treatment with PCI) are eligible for the study. Patients will only be included if they are able to understand the nature, scope, and possible consequences of study participation, and written informed consent will be sought.
•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 264
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 180

•Left bundle branch block; TIMI-flow >1 in the identified culprit artery; current (= 10 days) treatment with CsA or contraindication regarding treatment with CsA; coronary anatomy not suitable for PCI; thrombolytic therapy within 24 hrs. before randomization; previous myocardial infarction; previous CABG; severe renal or hepatic insufficiency; malignant tumor, not curatively treated; women with childbearing potential, esp. pregnant or nursing women; participation in another clinical or device trial within the previous 30 days.

发起方

IST. DI RICERCHE FARMACOLOG. M. NEGRI