Ranolazine Loading to Prevent PCI-induced Myocardial Injury (TWILIGHT)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||TWice overnIght High-dose ranoLazIne Pretreatment for preventinG Myocardial iscHemic Damage in Patients With Stable Angina Undergoing percuTaneous Coronary Intervention|
- Frequency of PCI-induced myocardial infarction [ Time Frame: Up to 48 hours after PCI ] [ Designated as safety issue: No ]Occurrence of peri-procedural myocardial infarction (i.e. creatine kinase-MB>3 times the upper reference limit)
- Assessment of post-PCI peak values of markers of myocardial damage [ Time Frame: Baseline and 48 hours after PCI ] [ Designated as safety issue: No ]Changes after percutaneous coronary intervention in absolute values of creatine kinase, creatine kinase-MB, myoglobin, and troponin I
- Rate of 30-day MACE [ Time Frame: Up to 30 days after PCI ] [ Designated as safety issue: No ]30-day incidence of major adverse cardiac events (MACE—death, myocardial infarction, target vessel revascularization)
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: 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)
os, 1,000 mg twice 12 hours apart prior to PCI
Other Name: Ranexa TM, Gilead, USA
Placebo Comparator: Placebo
os, two doses 12 hours apart prior to PCI
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491061
|Contact: Francesco Pelliccia, MDfirstname.lastname@example.org|
|San Raffaele Pisana||Not yet recruiting|
|Rome, Italy, 00100|
|Contact: Giuseppe Marazzi, MD +39 335 8381320 email@example.com|