Ranolazine Loading to Prevent PCI-induced Myocardial Injury

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Drug: Placebo; Drug: Ranolazine

• Registration Number: NCT01491061
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

It has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7 days can significantly reduce procedural myocardial injury in elective percutaneous coronary intervention (PCI). The investigators tested the hypothesis that twice overnight high-dose ranolazine loading before PCI can reduce the peri-procedural myocardial ischemic damage similarly to long-term pre-treatment with standard doses.

Detailed Description

Background

Ranolazine is a novel antianginal drug that reduces intracellular sodium and calcium accumulation during ischemia thus limiting ischemic injury.

It has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7 days can significantly reduce procedural myocardial injury in elective percutaneous coronary intervention.

It remains unknown, however, which of these two therapeutic approaches is more effective after PCI.

Purpose

The primary objective of this study is to test the hypothesis that twice overnight high-dose ranolazine loading before PCI can reduce the peri-procedural myocardial ischemic damage similarly to long-term pre-treatment with standard doses.

Study Timeline

• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2011-12-09
• Study First Posted: 2011-12-13
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-06
• Last Update Posted: 2013-03-07
• Study Start: 2014-01
• Primary Completion: 2015-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Angiographically-proven coronary artery disease
• Class I indication to elective percutaneous coronary intervention
• Stable conditions
• No recent acute coronary syndromes
• Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I)
• Able to understand and willing to sign the informed consent form

Exclusion Criteria

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Ranolazine	Ranolazine	Administration of two preprocedural doses of Ranolazine 12 hours apart (1,000 mg the night before PCI and 1,000 mg prior to PCI)

Primary Outcome Measures

Name	Time	Method
Frequency of PCI-induced myocardial infarction	Up to 48 hours after PCI	Occurrence of peri-procedural myocardial infarction (i.e. creatine kinase-MB\>3 times the upper reference limit)

Secondary Outcome Measures

Name	Time	Method
Assessment of post-PCI peak values of markers of myocardial damage	Baseline and 48 hours after PCI	Changes after percutaneous coronary intervention in absolute values of creatine kinase, creatine kinase-MB, myoglobin, and troponin I
Rate of 30-day MACE	Up to 30 days after PCI	30-day incidence of major adverse cardiac events (MACE-death, myocardial infarction, target vessel revascularization)

Trial Locations

Locations (1)

San Raffaele Pisana; 🇮🇹 Rome, Italy