Status:
COMPLETED
Pharmacodynamic and Pharmacokinetic of Switching From Cangrelor to Prasugrel in ACS Patients Undergoing PCI
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Scott R. MacKenzie Foundation
Conditions:
Coronary Artery Disease
Acute Coronary Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 coro...
Detailed Description
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 coro...
Eligibility Criteria
Inclusion
- 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
- 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 \[women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study\]
Key Trial Info
Start Date :
February 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2023
Estimated Enrollment :
359 Patients enrolled
Trial Details
Trial ID
NCT04668144
Start Date
February 18 2021
End Date
May 11 2023
Last Update
March 20 2024
Active Locations (1)
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1
University of Florida Jacksonville
Jacksonville, Florida, United States, 32209