NCT01491061

Ranolazine Loading to Prevent PCI-induced Myocardial Injury

TWice overnIght High-dose ranoLazIne Pretreatment for preventinG Myocardial iscHemic Damage in Patients With Stable Angina Undergoing percuTaneous Coronary Intervention

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Ranolazine	os, 1,000 mg twice 12 hours apart prior to PCI
DRUG	Placebo	os, two doses 12 hours apart prior to PCI

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-12-01
• Completion: 2017-12-01
• First posted: 2011-12-13
• Last updated: 2013-03-07

Locations

1 site across 1 country: Italy