CAD with acute ischemia and myocardial dysfunction MedDRA version: 14.1 Level: PT Classification code 10028600 Term: Myocardial ischaemia System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Ranexa
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: RANOLAZINE
CAS Number: 95635-55-5
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration numb
Sponsors
University Medical Center Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - Incidence of cardiac complications (i.e. ventricular tachycardia, re-infarction, rehospitalisation for revascularization) ;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
| Measure | Time frame |
|---|---|
| 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 • Level of cardiac markers (NT-pro-BNP, Troponine, CK, Copeptin) after 42 days treatment with Ranolazine ;Timepoint(s) of evaluation of this end point: Day 42 | — |
Countries
Germany
Contacts
Public ContactTjark Schwemer
University Medical Center Hamburg-Eppendorf
Outcome results
None listed