Ranolazine Cardioprotection in PCI

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ranolazine

Oral treatment Intervention: Drug: Ranolazine 1000 mg

Group Type ACTIVE_COMPARATOR

Ranolazine

Intervention Type DRUG

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

Placebo

Oral treatment Intervention: Drug: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Ranolazine

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Ranexa

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No