Ranolazine Cardioprotection in PCI

Acute Coronary Syndrome Clinical Trial

Official title:

Ranolazine Cardioprotection in PCI

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01767987
• Other study ID #: ISR IN-US-259-0139
• Status: Terminated
• Phase: Phase 2
• First received: November 28, 2012
• Last updated: October 20, 2015
• Start date: November 2012
• Est. completion date: April 2014

Study information

• Verified date: October 2015
• Source: Kettering Health Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Kettering Medical Center	Kettering	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Harvey Hahn	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin	Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first	8-10 hrs post PCI	No
Primary	CK-MB	CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first	8-10 hrs post PCI	No
Secondary	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.	TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure.	No
Secondary	Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab	Abnormal heart activity	During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire	Yes
Secondary	Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI		Following completion of PCI through hospital discharge	Yes
Secondary	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	No
Secondary	Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest		At discharge or within 1 days, whichever comes first	Yes
Secondary	Death, MI, Revascularization, CHF		1-4 weeks post PCI	Yes
Secondary	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.	At discharge or within 1 days, whichever comes first	Yes