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Ranolazine Cardioprotection in PCI

Primary Purpose

Acute Coronary Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ranolazine
Placebo
Sponsored by
Harvey Hahn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, ACS, Percutaneous Coronary Intervention, PCI, Ranolazine, Coronary Angiogram, Cardioprotectant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kettering Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ranolazine

Placebo

Arm Description

Oral treatment Intervention: Drug: Ranolazine 1000 mg

Oral treatment Intervention: Drug: Placebo

Outcomes

Primary Outcome Measures

Troponin
Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
CK-MB
CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first

Secondary Outcome Measures

TIMI Flow Rate (Grade)
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
Abnormal heart activity
Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI
Left Ventricular End Diastolic Pressure (LVEDP)
Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest
Death, MI, Revascularization, CHF
Successful PCI
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.

Full Information

First Posted
November 28, 2012
Last Updated
August 16, 2017
Sponsor
Harvey Hahn
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01767987
Brief Title
Ranolazine Cardioprotection in PCI
Official Title
Ranolazine Cardioprotection in PCI
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Sponsor terminated study due to lack of enrollment
Study Start Date
November 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Harvey Hahn
Collaborators
Gilead Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Acute Coronary Syndrome, ACS, Percutaneous Coronary Intervention, PCI, Ranolazine, Coronary Angiogram, Cardioprotectant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranolazine
Arm Type
Active Comparator
Arm Description
Oral treatment Intervention: Drug: Ranolazine 1000 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral treatment Intervention: Drug: Placebo
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
Ranexa
Intervention Description
Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
Primary Outcome Measure Information:
Title
Troponin
Description
Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
Time Frame
8-10 hrs post PCI
Title
CK-MB
Description
CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
Time Frame
8-10 hrs post PCI
Secondary Outcome Measure Information:
Title
TIMI Flow Rate (Grade)
Description
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.
Time Frame
TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure.
Title
Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab
Description
Abnormal heart activity
Time Frame
During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire
Title
Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI
Time Frame
Following completion of PCI through hospital discharge
Title
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
Title
Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest
Time Frame
At discharge or within 1 days, whichever comes first
Title
Death, MI, Revascularization, CHF
Time Frame
1-4 weeks post PCI
Title
Successful PCI
Description
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.
Time Frame
At discharge or within 1 days, whichever comes first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harvey S Hahn, MD
Organizational Affiliation
Kettering Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Ranolazine Cardioprotection in PCI

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