Reduction of Ischemic Myocardium with Ranolazine-Treatment in patients with acute myocardial Ischemia

Conditions: CAD with acute ischemia and myocardial dysfunction
MedDRA version: 14.1Level: PTClassification code 10028600Term: Myocardial ischaemiaSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-000030-35-DE

Lead Sponsor: niversity Medical Center Hamburg-Eppendorf

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Area of ischemic myocardium/cm² (longitudinal strain, radial/circumferential strain) after 42 days treatment with Ranolazine;Secondary Objective: -Level of cardiac markers (NT-pro-BNP, Troponine, CK, Copeptin) after 42 days treatment with Ranolazine<br>-Incidence of cardiac complications (i.e. ventricular tachycardia, re-infarction, rehospitalisation for revascularization)<br>;Primary end point(s): Area of ischemic myocardium/cm² (longitudinal strain, radial/circumferential strain) after 42 days treatment with Ranolazine;Timepoint(s) of evaluation of this end point: Day 42

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Incidence of cardiac complications (i.e. ventricular tachycardia, re-infarction, rehospitalisation for revascularization) after 42 days treatment ofacutmyocardial ischemia with Ranolazine<br><br>•Level of cardiac markers (NT-pro-BNP, Troponine, CK, Copeptin) after 42 days treatment with Ranolazine<br>;Timepoint(s) of evaluation of this end point: Day 42