Ignite Creation Date:
2024-05-06 @ 1:14 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01767987
Status:
TERMINATED
Last Update Posted:
2017-09-14
First Post:
2012-11-28
Brief Title:
Ranolazine Cardioprotection in PCI
Sponsor:
Harvey Hahn
Organization:
Kettering Health Network
Study Overview
Official Title:
Ranolazine Cardioprotection in PCI
Status:
TERMINATED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor terminated study due to lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker release CK-MB Troponin post percutaneous coronary intervention PCI
Detailed Description:
Ranolazine has been demonstrated to decrease angina ischemia on perfusion imaging improve diastolic function and cardiac metabolism Furthermore it has been associated with reduced cardiac arrhythmias including non-sustained ventricular tachycardia and atrial fibrillation It has not been studied as an acute cardioprotective agent in percutaneous coronary intervention PCI
We hypothesize that upfront administration of Ranolazine could decrease the myocardial injury associated with PCI due to all the factors listed above ie precondition the myocardium We plan to screen all patients scheduled for an elective coronary angiogram Those who meet criteria and consent will be randomized to either receive Ranolazine or placebo twice a day for 3 days leading up to the PCI
We hypothesize that upfront administration of Ranolazine could decrease the myocardial injury associated with PCI due to all the factors listed above ie precondition the myocardium We plan to screen all patients scheduled for an elective coronary angiogram Those who meet criteria and consent will be randomized to either receive Ranolazine or placebo twice a day for 3 days leading up to the PCI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None