CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
Ranolazinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01797484
NCT01797484Phase 3Completed

Reduction of Ischemic Myocardium With Ranolazine-Treatment in Patients With Acute Myocardial Ischemia

Universitätsklinikum Hamburg-Eppendorf·interventional·Posted Feb 22, 2013·Updated Jan 12, 2018

In Brief

A Phase 3 clinical trial evaluating Ranolazine for Coronary Artery Disease and Acute Myocardial Ischemia. Completed, enrolled 20 participants across 1 site.

Detailed 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 ischemic myocardium in patients with stable coronary artery disease can be reduced by Ranolazine-treatment2. This effect was shown by significantly reduced areas of atypical or dysfunctional myocardium in SPECT-examinations. The dimension of myocardial damage (i.e. area of ischemic myocardium) is directly related to the rate of complications (i.e. left-ventricular pump failure, malignant arrhythmia) and the grade of Rehabilitation to daily life (i.e. persistent reduced left-ventricular ejection fraction). In patients with stable angina pectoris, Ranolazine is used with beneficial results1. Ranolazine improves diastolic blood flow and therefore microcirculation in the myocardium by reducing diastolic tension (via inhibiting late Na+-Influx and consecutive Ca2+-Overload). Recently published data2 showed that treatment with Ranolazine significantly reduces the ischemic area in chronic damaged myocardium. This is due the effect of improved microcirculation in hibernating myocardium. Early administration of Ranolazine and improvement of microcirculation in patients with acute damaged myocardium (i.e. directly after acute ischemia) should lead to a recruitment and re-uptake of cardiac activity of hibernating myocardium. For the RIMINI-Trial patients are given Ranolazine on top of the guideline-based treatment to reduce the area of acute ischemic myocardium. Patients with unstable angina pectoris and proof of acute cardiac ischemia, proof of myocardial dyskinesia and angina pectoris in the patient history will receive unaltered guideline-based therapy for acute cardiac ischemia5,6. All necessary procedures will be performed to stabilize patients to a hemodynamically compensated state and patients are then transferred to receive cardiac catheterization (angiography and angioplasty if necessary). After patients are stabilized Ranolazine will be given additionally to guideline based medication. The measurement of the ischemic myocardial area will be done via three functional echocardiographies with speckle tracking technique10. A statistical evaluation of ischemic myocardial area before and after treatment with Ranolazine/Placebo will be done after conclusion of the RIMINI-Trial to show the effect of Ranolazine in acute myocardial ischemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 22, 2013
Enrollment StartAug 1, 2013
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.4 years ago

Interventions

Ranolazinedrug

Improvement of myocardial microcirculation