Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT04790032
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2021-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacodynamic Effects of Cangrelor in ACS or CCS Patients Undergoing PCI (POMPEII Registry)
Sponsor:
Federico II University
Organization:
Study Overview
Official Title:
PharmacOdynaMic Effects of Cangrelor in PatiEnts wIth Acute or chronIc Coronary Syndrome Undergoing Percutaneous Coronary Intervention (POMPEII Registry)
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POMPEII
Brief Summary:
This prospective registry was designed to carefully investigate the pharmacodynamic (PD) effects of cangrelor in all patients undergoing percutaneous coronary intervention (PCI).
Detailed Description:
There is huge interest in achieving fast and immediate antiplatelet effect at the time of PCI, particularly in acute myocardial infarction and Cangrelor is an intravenous antagonist of the P2Y12 receptor characterized by rapid, potent, predictable, and reversible platelet inhibition. However, there are limited pharmacodynamic data exploring the effects of this drug in the various clinical settings at the approved dosages and with current gold standard methods for testing platelet reactivity. More importantly, there are no data on rates and predictors of high residual platelet reactivity (HRPR) in patients treated with cangrelor. Therefore the present study aims at building up a large prospective registry of pharmacodynamic data obtained by light transmittance aggregometry (LTA), multiplate analysis and verifynow system in patients undergoing PCI and receiving cangrelor.
This study is designed as a single-center prospective registry. Investigators at University Hospital of Naples Federico II will enroll patients, collect blood samples, perform platelet function tests and collect clinical and demographic information.
This study is designed as a single-center prospective registry. Investigators at University Hospital of Naples Federico II will enroll patients, collect blood samples, perform platelet function tests and collect clinical and demographic information.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: