Reduction of Ischemic Myocardium with Ranolazine-Treatment in patients with acute myocardial Ischemia – RIMINI-Pilot-Trial

niversity Medical Center Hamburg-Eppendorf0 个研究点开始时间: 2013年2月26日最近更新: 2016年1月11日

适应症

试验速览

暂无简介。

•- Proof of acute cardiac ischemia by elevated serum Troponine T-hs levels > 14 pg/ml
•- Proof of myocardial dyskinesia with functional echocardiography (speckle tracking”)
•- stable angina pectoris >/= CCS II in the patient history
•- Stabilized (i.e. normalized vital parameters, refer to 2. Study Rationale for further explanation) patients after coronary angioplasty or angiography
•- Coronary angioplasty or angiography not older than 24 h
•- Written informed consent
•- Established standard therapy for coronary artery disease (i.e. Beta-Blocker, ACE-Inhibitor or AT1-Inhibitor, ASS, Clopidogrel, Statins)
•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 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- Patients younger than 18 years of age
•- Acute cardio-pulmonary decompensation
•- Middle and high grade liver insufficiency (Child-Pugh Score B and C)
•- High grade renal insufficiency (Creatinine-Clearance < 30 ml/min)
•- Concomitant treatment with potent inhibitors of CYP3A4
•- Concomitant administration of class Ia (e.g. quinidine) or class III (e.g. dofetilide, sotalol) antiarrhythmics, except for amiodarone
•- Concomitant administration of > 20 mg simvastatin/day
•- Patients with heart failure classification NYHA III and NYHA IV
•- Homeless patients and drug-addicted patients
•- Pregnant and/or breast-feeding women
•- Treatment with Ranolazine prior to enrollement in RIMINI-Trial
•- Allergy against Ranolazine

发起方

niversity Medical Center Hamburg-Eppendorf