NCT01767987

Brief Summary

The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 15, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

November 20, 2015

Completed
Last Updated

September 14, 2017

Status Verified

August 1, 2017

Enrollment Period

1.4 years

First QC Date

November 28, 2012

Results QC Date

September 9, 2014

Last Update Submit

August 16, 2017

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary SyndromeACSPercutaneous Coronary InterventionPCIRanolazineCoronary AngiogramCardioprotectant

Outcome Measures

Primary Outcomes (2)

  • Troponin

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

    8-10 hrs post PCI

  • CK-MB

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

    8-10 hrs post PCI

Secondary Outcomes (7)

  • TIMI Flow Rate (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

    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

    Following completion of PCI through hospital discharge

  • Left Ventricular End Diastolic Pressure (LVEDP)

    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

    At discharge or within 1 days, whichever comes first

  • +2 more secondary outcomes

Study Arms (2)

Ranolazine

ACTIVE COMPARATOR

Oral treatment Intervention: Drug: Ranolazine 1000 mg

Drug: Ranolazine

Placebo

PLACEBO COMPARATOR

Oral treatment Intervention: Drug: Placebo

Drug: Placebo

Interventions

RanolazineDRUG

Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI

Also known as: Ranexa
Ranolazine
PlaceboDRUG

Drug: Placebo Oral dose twice per day for 3 days leading up to PCI

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Patients undergoing Coronary Angiography with possible PCI
  • Able and willing to give consent
  • Able to read and write English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Suzanne Coleman, PhD
Organization
Kettering Health Network
suzanne.coleman@khnetwork.org
937-395-8390

Study Officials

  • Harvey S Hahn, MD

    Kettering Health Network

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Cardiovascular Fellowship Training Program and Director, Cardiac Noninvasive Laboratory

Study Record Dates

First Submitted

November 28, 2012

First Posted

January 15, 2013

Study Start

November 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

September 14, 2017

Results First Posted

November 20, 2015

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)