Coronary Artery Disease
Conditions
Keywords
periprocedural myocardial infarction, ranolazine
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.
Interventions
DRUGRanolazine
os, 1,000 mg twice 12 hours apart prior to PCI
DRUGPlacebo
os, two doses 12 hours apart prior to PCI
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Italy
Contacts
Primary ContactFrancesco Pelliccia, MD
Outcome results
None listed