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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
os, 1,000 mg twice 12 hours apart prior to PCI
os, two doses 12 hours apart prior to PCI
San Raffaele Pisana
Rome, Italy
Frequency of PCI-induced myocardial infarction
Occurrence of peri-procedural myocardial infarction (i.e. creatine kinase-MB\>3 times the upper reference limit)
Time frame: Up to 48 hours after PCI
Assessment of post-PCI peak values of markers of myocardial damage
Changes after percutaneous coronary intervention in absolute values of creatine kinase, creatine kinase-MB, myoglobin, and troponin I
Time frame: Baseline and 48 hours after PCI
Rate of 30-day MACE
30-day incidence of major adverse cardiac events (MACE-death, myocardial infarction, target vessel revascularization)
Time frame: Up to 30 days after PCI
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