Ranolazine Cardioprotection in PCI

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Kettering Health Network
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: May 2, 2013
Last verified: May 2013
  Purpose

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 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 ]

Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Primary Completion Date: November 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Harvey S Hahn, MD 937-312-9890 harvey.hahn@khnetwork.org
Contact: Brandi L Palmer, MS 937-395-8227 brandi.palmer@khnetwork.org

Locations
United States, Ohio
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
Principal Investigator: Harvey Hahn, MD         
Sponsors and Collaborators
Harvey Hahn
Gilead Sciences
Investigators
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
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Kettering Health Network:
Acute Coronary Syndrome
ACS
Percutaneous Coronary Intervention
PCI
Ranolazine
Coronary Angiogram
Cardioprotectant

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

ClinicalTrials.gov processed this record on October 22, 2014