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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine | Active Comparator | Administration of two preprocedural doses of Ranolazine 12 hours apart (1,000 mg the night before PCI and 1,000 mg prior to PCI) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | os, 1,000 mg twice 12 hours apart prior to PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of PCI-induced myocardial infarction | Occurrence of peri-procedural myocardial infarction (i.e. creatine kinase-MB>3 times the upper reference limit) | Up to 48 hours after PCI |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 48 hours after PCI |
| Rate of 30-day MACE |
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Inclusion Criteria:
Exclusion Criteria:
• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Pelliccia, MD | Contact | +393483392006 | f.pelliccia@mclink.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Pisana | Rome | 00100 | Italy |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo | Drug | os, two doses 12 hours apart prior to PCI |
|
30-day incidence of major adverse cardiac events (MACE-death, myocardial infarction, target vessel revascularization) |
| Up to 30 days after PCI |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |