Ranolazine Cardioprotection in PCI

This study has been terminated.
(Sponsor terminated study due to lack of enrollment)
Gilead Sciences
Information provided by (Responsible Party):
Harvey Hahn, Kettering Health Network
ClinicalTrials.gov Identifier:
First received: November 28, 2012
Last updated: October 20, 2015
Last verified: October 2015
The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).

Condition Intervention Phase
Acute Coronary Syndrome
Drug: Ranolazine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Ranolazine Cardioprotection in PCI

Resource links provided by NLM:

Further study details as provided by Kettering Health Network:

Primary Outcome Measures:
  • Troponin [ Time Frame: 8-10 hrs post PCI ] [ Designated as safety issue: No ]
    Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first

  • CK-MB [ Time Frame: 8-10 hrs post PCI ] [ Designated as safety issue: No ]
    CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first

Secondary Outcome Measures:
  • TIMI Flow Rate (Grade) [ Time Frame: TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure. ] [ Designated as safety issue: No ]

    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 Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab [ Time Frame: During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire ] [ Designated as safety issue: Yes ]
    Abnormal heart activity

  • Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI [ Time Frame: Following completion of PCI through hospital discharge ] [ Designated as safety issue: Yes ]
  • Left Ventricular End Diastolic Pressure (LVEDP) [ Time Frame: During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire ] [ Designated as safety issue: No ]
  • Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest [ Time Frame: At discharge or within 1 days, whichever comes first ] [ Designated as safety issue: Yes ]
  • Death, MI, Revascularization, CHF [ Time Frame: 1-4 weeks post PCI ] [ Designated as safety issue: Yes ]
  • Successful PCI [ Time Frame: At discharge or within 1 days, whichever comes first ] [ Designated as safety issue: Yes ]
    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.

Enrollment: 6
Study Start Date: November 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ranolazine
Oral treatment Intervention: Drug: Ranolazine 1000 mg
Drug: Ranolazine
Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI
Other Name: Ranexa
Placebo Comparator: Placebo
Oral treatment Intervention: Drug: Placebo
Drug: Placebo
Drug: Placebo Oral dose twice per day for 3 days leading up to 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01767987

United States, Ohio
Kettering Medical Center
Kettering, Ohio, United States, 45429
Sponsors and Collaborators
Harvey Hahn
Gilead Sciences
Principal Investigator: Harvey S Hahn, MD Kettering Health Network
  More Information

No publications provided

Responsible Party: Harvey Hahn, Director, Cardiovascular Fellowship Training Program and Director, Cardiac Noninvasive Laboratory, Kettering Health Network
ClinicalTrials.gov Identifier: NCT01767987     History of Changes
Other Study ID Numbers: ISR IN-US-259-0139
Study First Received: November 28, 2012
Results First Received: September 9, 2014
Last Updated: October 20, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Kettering Health Network:
Acute Coronary Syndrome
Percutaneous Coronary Intervention
Coronary Angiogram

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Signs and Symptoms
Vascular Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2015