Ranolazine Cardioprotection in PCI

This study has been terminated.
(Sponsor terminated study due to lack of enrollment)
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Harvey Hahn, Kettering Health Network
ClinicalTrials.gov Identifier:
NCT01767987
First received: November 28, 2012
Last updated: October 20, 2015
Last verified: October 2015

November 28, 2012
October 20, 2015
November 2012
April 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01767987 on ClinicalTrials.gov Archive Site
  • 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.
  • TIMI flow rates [ Time Frame: During the PCI ] [ Designated as safety issue: No ]
  • Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab [ Time Frame: During the PCI ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Successful PCI, 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 ]
Not Provided
Not Provided
 
Ranolazine Cardioprotection in PCI
Ranolazine Cardioprotection in PCI
The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Acute Coronary Syndrome
  • Drug: Ranolazine
    Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI
    Other Name: Ranexa
  • Drug: Placebo
    Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
  • Active Comparator: Ranolazine
    Oral treatment Intervention: Drug: Ranolazine 1000 mg
    Intervention: Drug: Ranolazine
  • Placebo Comparator: Placebo
    Oral treatment Intervention: Drug: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01767987
ISR IN-US-259-0139
No
Not Provided
Not Provided
Harvey Hahn, Kettering Health Network
Harvey Hahn
Gilead Sciences
Principal Investigator: Harvey S Hahn, MD Kettering Health Network
Kettering Health Network
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP