Ranolazine Cardioprotection in PCI

August 16, 2017 updated by: Harvey Hahn
The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Troponin
Time Frame: 8-10 hrs post PCI
Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
8-10 hrs post PCI
CK-MB
Time Frame: 8-10 hrs post PCI
CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
8-10 hrs post PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvey Hahn

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Harvey S Hahn, MD, Kettering Health Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

November 28, 2012

First Submitted That Met QC Criteria

January 11, 2013

First Posted (ESTIMATE)

January 15, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISR IN-US-259-0139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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