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Reduction of Ischemic Myocardium With Ranolazine-Treatment in Patients With Acute Myocardial Ischemia (RIMINI-Pilot)

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ClinicalTrials.gov Identifier: NCT01797484
Recruitment Status : Completed
First Posted : February 22, 2013
Last Update Posted : June 11, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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 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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Acute Myocardial Ischemia Drug: Ranolazine Phase 2 Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reduction of Ischemic Myocardium With Ranolazine-Treatment in Patients With Acute Myocardial Ischemia
Study Start Date : July 2013
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ranolazine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Ranolazine
Ranolazine 500mg bid orally 7 days Ranolazine 750mg bid orally 35 days
Drug: Ranolazine
Improvement of myocardial microcirculation
Other Name: Ranexa
No Intervention: No additional medication
No additional medication - control group


Outcome Measures

Primary Outcome Measures :
  1. Area of ischemic myocardium/cm² (longitudinal strain, radial/circumferential strain) [ Time Frame: 42 days after first dose of Ranolazine ]

Secondary Outcome Measures :
  1. Incidence of cardiac complications (i.e. ventricular tachycardia, re-infarction, rehospitalisation for revascularization) [ Time Frame: 42 days after first dose of Ranolazine ]
  2. Level of cardiac markers (NT-pro-BNP, Troponin, CK, Copeptin) [ Time Frame: Before and 42 days after first dose of Ranolazine ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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 enrolment in RIMINI-Trial
  • Allergy against Ranolazine
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797484


Locations
Germany
University Heart Center Hamburg Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Stefan Blankenberg, Prof. Dr. Director of University Heart Center Hamburg Eppendorf
More Information

Additional Information:
Publications:

Responsible Party: Tjark Frederik Schwemer, Dr. med., Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01797484     History of Changes
Other Study ID Numbers: UHZ-KARD-01-2013
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015

Keywords provided by Tjark Frederik Schwemer, Universitätsklinikum Hamburg-Eppendorf:
ischemia
myocardium
Ranolazine
dyskinesia
speckle tracking echocardiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action