Ranolazine Cardioprotection in PCI

Phase 2

Terminated

Conditions: Acute Coronary Syndrome

Interventions: Drug: Placebo
Drug: Ranolazine

Registration Number: NCT01767987

Lead Sponsor: Harvey Hahn

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

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 6

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Oral treatment Intervention: Drug: Placebo
Ranolazine	Ranolazine	Oral treatment Intervention: Drug: Ranolazine 1000 mg

Primary Outcome Measures

Name	Time	Method
Troponin	8-10 hrs post PCI	Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
CK-MB	8-10 hrs post PCI	CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first

Secondary Outcome Measures

Name	Time	Method
TIMI Flow Rate (Grade)	TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure.	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.
Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI	Following completion of PCI through hospital discharge
Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest	At discharge or within 1 days, whichever comes first
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
Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab	During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire	Abnormal heart activity
Death, MI, Revascularization, CHF	1-4 weeks post PCI
Successful PCI	At discharge or within 1 days, whichever comes first	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.