Ranolazine Cardioprotection in PCI

Study Overview
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Brief Summary
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The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).

Detailed Description
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Ranolazine has been demonstrated to decrease angina, ischemia on perfusion imaging, improve diastolic function, and cardiac metabolism. Furthermore it has been associated with reduced cardiac arrhythmias, including non-sustained ventricular tachycardia and atrial fibrillation. It has not been studied as an acute cardioprotective agent in percutaneous coronary intervention (PCI). We hypothesize that upfront administration of Ranolazine could decrease the myocardial injury associated with PCI due to all the factors listed above (i.e. precondition the myocardium). We plan to screen all patients scheduled for an elective coronary angiogram. Those who meet criteria and consent will be randomized to either receive Ranolazine or placebo twice a day for 3 days leading up to the PCI.

Official Title
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Ranolazine Cardioprotection in PCI

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Ranolazine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Patients undergoing Coronary Angiography with possible PCI Able and willing to give consent Able to read and write English Exclusion Criteria: Current EKG or Biomarker of Acute Myocardial Infarction (MI) or Acute Coronary Syndromes (ACS) History of Allergy to Ranolazine Pregnant or Nursing Currently taking Ranolazine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ranolazine<br>Oral treatment Intervention: Drug: Ranolazine 1000 mg | Drug: Ranolazine<br>* Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI<br>* Other names: Ranexa;|
| Placebo Comparator: Placebo<br>Oral treatment Intervention: Drug: Placebo | Drug: Placebo<br>* Drug: Placebo Oral dose twice per day for 3 days leading up to PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Troponin | Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first | 8-10 hrs post PCI | 
| CK-MB | CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first | 8-10 hrs post PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIMI Flow Rate (Grade) | This TIMI classification was developed by the TIMI (Thrombolysis In Myocardial Infarction) study group to semiquantitatively assess coronary artery perfusion beyond point of occlusion on coronary angiography.* TIMI Grade [Description] TIMI 0 - no perfusion [no antegrade flow beyond the point of occlusion] TIMI 1 - penetration without perfusion [faint antegrade coronary flow beyond the occlusion with incomplete filling of the distal coronary bed] TIMI 2 - partial perfusion [delayed or sluggish antegrade flow with complete filling of the distal territory] TIMI 3 - complete perfusion [normal flow with complete filling of the distal territory] *(see http://radclass.mudr.org/content/timi-grade-flow-grading-coronary-blood-flow-during-coronary-angiography) TIMI 0 is the least favorable grade. TIMI 3 is the most favorable grade. | TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure. | 
| Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab | Abnormal heart activity | During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire | 
| Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI |  | Following completion of PCI through hospital discharge | 
| Left Ventricular End Diastolic Pressure (LVEDP) |  | During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire | 
| Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest |  | At discharge or within 1 days, whichever comes first | 
| Death, MI, Revascularization, CHF |  | 1-4 weeks post PCI | 
| Successful PCI | For the purposes of this study, a successful PCI is considered one where no additional coronary interventions were required within 24 hours after the initial PCI. | At discharge or within 1 days, whichever comes first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, ACS, Percutaneous Coronary Intervention, PCI, Ranolazine, Coronary Angiogram, Cardioprotectant