Status:
COMPLETED
Reduction of Ischemic Myocardium With Ranolazine-Treatment in Patients With Acute Myocardial Ischemia
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Coronary Artery Disease
Acute Myocardial Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of the RIMINI-Trial is to examine the effect of Ranolazine on ischemic myocardium in acute myocardial ischemia. A pilot-trial by Venkatamaran et al. recently demonstrated, that the area of is...
Detailed Description
The aim of the RIMINI-Trial is to examine the effect of Ranolazine on ischemic myocardium in acute myocardial ischemia. A pilot-trial by Venkatamaran et al. recently demonstrated, that the area of is...
Eligibility Criteria
Inclusion
- Proof of acute cardiac ischemia by elevated serum Troponin T-hs levels \> 14 pg/nl
- Proof of myocardial dyskinesia with functional echocardiography ("speckle tracking")
- Stable angina pectoris \>/= CCS II in patient history
- Stabilized (i.e. normalized vital parameters) patients after coronary angioplasty or angiography
- Coronary angioplasty or angiography not older than 24 hours
- Written informed consent
- Established standard therapy for coronary artery disease (i.e. Beta-Blocker, ACE-Inhibitor or AT1-Inhibitor, ASS, Clopidogrel, Statins)
Exclusion
- 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 enrolment in RIMINI-Trial
- Allergy against Ranolazine
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01797484
Start Date
August 1 2013
End Date
June 1 2015
Last Update
January 12 2018
Active Locations (1)
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1
University Heart Center Hamburg Eppendorf
Hamburg, Germany, 20246