Ignite Creation Date:
2024-05-06 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03247738
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2017-08-07
Brief Title:
Platelet Inhibition With Cangrelor and Crushed Ticagrelor in STEMI
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Platelet Inhibition With CANgrelor and Crushed TICagrelor in STEMI Patients Undergoing Primary Percutaneous Coronary Intervention The CANTIC Study
Status:
COMPLETED
Status Verified Date:
2020-08
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:
CANTIC
Brief Summary:
In STEMI patients undergoing PPCI there is a delayed onset of action of oral P2Y12 receptor inhibitors including prasugrel and ticagrelor Crushing prasugrel and ticagrelor improves their PK and PD profiles as it favors drug absorption and onset of antiplatelet effects and because of this it is commonly used in STEMI patients undergoing PPCI However despite the use of crushed tablets up to one-third of patients may still have high on-treatment platelet reactivity HPR within the first 2 hours after loading dose LD administration of these oral agents Cangrelor is a potent intravenous P2Y12 receptor inhibitor with rapid onset and offset of action associated with a greater reduction in ischemic events compared with clopidogrel in P2Y12 receptor naïve patients undergoing PCI To date most studies have explored cangrelor in the setting of PCI subjects treated with clopidogrel The PD effects of cangrelor in STEMI patients undergoing PPCI treated with a newer generation P2Y12 receptor inhibitor and how this compares with a crushed formulation of the oral drug is unexplored The aim of this prospective randomized study is to investigate the PD effects of cangrelor in STEMI patients undergoing PPCI treated with crushed ticagrelor
Detailed Description:
In STEMI patients undergoing PPCI there is a delayed onset of action of oral P2Y12 receptor inhibitors including prasugrel and ticagrelor which require more than 2 hours to exert their full antiplatelet effects and thus exposing these high-risk patients to an increased risk of early thrombotic complications The mechanism of this delayed onset of antiplatelet effect is likely multifactorial due to the presence in the setting of STEMI of specific conditions that translate into delayed drug absorption which in turn affect the pharmacokinetic PK and pharmacodynamic PD profiles of oral P2Y12 receptor inhibitors Crushing prasugrel and ticagrelor improves their PK and PD profiles as it favors drug absorption and onset of antiplatelet effects and because of this it is commonly used in STEMI patients undergoing PPCI However despite the use of crushed tablets up to one-third of patients may still have high on-treatment platelet reactivity HPR within the first 2 hours after loading dose LD administration of these oral agents Cangrelor is a potent intravenous P2Y12 receptor inhibitor with rapid onset and offset of action associated with a greater reduction in ischemic events compared with clopidogrel in P2Y12 receptor naïve patients undergoing PCI To date most studies have explored cangrelor in the setting of PCI subjects treated with clopidogrel and the clinical profile of cangrelor among patients treated with prasugrel or ticagrelor is currently unknown This is noteworthy because ACS patients in particular STEMI undergoing PPCI are commonly treated with either prasugrel or ticagrelor PD investigations conducted in vitro or ex vivo in stable patients have shown cangrelor to be associated with enhanced platelet inhibition compared with that induced by prasugrel and ticagrelor However the PD effects of cangrelor in STEMI patients undergoing PPCI treated with a newer generation P2Y12 receptor inhibitor and how this compares with a crushed formulation of the oral drug is unexplored The aim of this prospective randomized study is to investigate the PD effects of cangrelor in STEMI patients undergoing PPCI treated with crushed ticagrelor
Study Oversight
Has Oversight DMC:
None
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?:
None