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Ranolazine Cardioprotection in PCI

H

Harvey Hahn

Status and phase

Terminated
Phase 2

Conditions

Acute Coronary Syndrome

Treatments

Drug: Ranolazine
Drug: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01767987
ISR IN-US-259-0139

Details and patient eligibility

About

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

Full 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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

6 participants in 2 patient groups, including a placebo group

Ranolazine
Active Comparator group
Description:
Oral treatment Intervention: Drug: Ranolazine 1000 mg
Treatment:
Drug: Ranolazine
Placebo
Placebo Comparator group
Description:
Oral treatment Intervention: Drug: Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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