Pharmacodynamic and Pharmacokinetic of Switching From Cangrelor to Prasugrel in ACS Patients Undergoing PCI

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Cangrelor is an intravenous P2Y12 inhibitor utilized as a bridge to achieve adequate platelet inhibition until oral P2Y12 inhibitors achieve their full antiplatelet effects in patients undergoing coronary stenting. Although in this setting the potent oral P2Y12 inhibitor prasugrel is commonly utilized, there is very limited data on the optimal approach for switching between these therapies. The overarching aim of this investigation is to rule out a drug drug interaction (DDI) when cangrelor and prasugrel are concomitantly administered in patients undergoing coronary stenting.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborators: Scott R MacKenzie Foundation; Scott R. MacKenzie Foundation
• Treatments: Cangrelor; Prasugrel Hydrochloride

Criteria

Inclusion Criteria:

• Patients with NSTE-ACS (UA or NSTEMI) undergoing PCI. NSTE-ACS will be defined as the presence of cardiac ischemic symptoms with ischemic changes (but not ST-segment elevation) on electrocardiogram with or without a positive troponin. However, normal electrocardiograms will be acceptable if the investigator will consider an ACS presentation likely.

• Age between 18 and 75 years old

Exclusion Criteria:

• Inability to provide written informed consent

• Age >75 years

• Weight <60 Kg

• ST-segment elevation myocardial infarction

• On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor) in past 7 days

• Known allergies to prasugrel or cangrelor

• Considered at high risk for bleeding

• History of ischemic or hemorrhagic stroke or transient ischemic attack

• On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxoban)

• Planned treatment with glycoprotein IIb/IIIa inhibitors (only bailout use allowed)

• Fibrinolytics within 24 hours

• Known platelet count <80x106/mL

• Known hemoglobin <10 g/dL

• Active bleeding

• Known end stage renal disease on hemodialysis

• Known severe hepatic dysfunction

• Intubated patients (prior to randomization)

• Pregnant females [women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study]