Clinical trial NCT01767987: Ranolazine Cardioprotection in PCI
Official title: Ranolazine Cardioprotection in PCI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome
ACS
Percutaneous Coronary Intervention
PCI
Ranolazine
Coronary Angiogram
Cardioprotectant
Lead sponsor: Kettering Health Network
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2013-01-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Troponin
timeFrame: 8-10 hrs post PCI
measure: CK-MB
timeFrame: 8-10 hrs post PCI
Secondary outcomes:
measure: TIMI Flow Rate (Grade)
timeFrame: TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure.
measure: Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab
timeFrame: During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire
measure: Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI
timeFrame: Following completion of PCI through hospital discharge
measure: Left Ventricular End Diastolic Pressure (LVEDP)
timeFrame: During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire
measure: Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest
timeFrame: At discharge or within 1 days, whichever comes first
measure: Death, MI, Revascularization, CHF
timeFrame: 1-4 weeks post PCI
measure: Successful PCI
timeFrame: At discharge or within 1 days, whichever comes first
Other outcomes:
Locations:
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
Study officials:
affiliation: Kettering Health Network
name: Harvey S Hahn, MD
role: PRINCIPAL_INVESTIGATOR
References: