Ranolazine Loading to Prevent PCI-induced Myocardial Injury
NCT ID: NCT01491061
Last Updated: 2013-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2014-01-31
2017-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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)
Ranolazine
os, 1,000 mg twice 12 hours apart prior to PCI
Placebo
Placebo
Placebo
os, two doses 12 hours apart prior to PCI
Interventions
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Ranolazine
os, 1,000 mg twice 12 hours apart prior to PCI
Placebo
os, two doses 12 hours apart prior to PCI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Francesco Pelliccia
Assistant Professor
Locations
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San Raffaele Pisana
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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653/2011/D
Identifier Type: -
Identifier Source: org_study_id
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