A dose-ranging study of bolus-only Desirudin in patients undergoing PCI

Canyon Pharmaceuticals, Inc.0 个研究点目标入组 80 人开始时间: 2009年6月9日最近更新: 2014年10月7日

试验速览

暂无简介。

•Patients due to undergo an elective (non-urgent) PCI on one or multiple lesions in the native coronary vessel(s) via a femoral approach;
•Indication for PCI: stable or unstable angina (without Troponin rise), or silent myocardial ischemia;
•At least 18 years old,
•Providing written informed consent before initiation of any study related procedures,
•Being pre-treated with a 600-mg loading dose of clopidogrel and aspirin at least 6 hours before the intervention or on chronic clopidogrel/aspirin treatment
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients are excluded from this study if:
•?They passed the upper age limit 85 years,
•?Lactating/pregnant women,
•?Body weight <40kg,
•?Not a candidate for PCI,
•?Experienced a Acute Myocardial Infarction within previous 4 weeks;
•?Angina Braunwald class A and C, Troponin positive/CK-MB above ULN at screening
•?New York Heart Association class III or IV congestive heart failure,
•?Hemodynamic instability,
•?Severe hypertension,
•?Significant valvular disease,
•?Increased bleeding risk,
•?Use of non-steroidal inflammatory drug (NSAID) within 12h prior to PCI
•?Taking part in any other medical study, including its follow-up phase

发起方