Status:
COMPLETED
Platelet Inhibition With Cangrelor and Crushed Ticagrelor in STEMI
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Chiesi Farmaceutici S.p.A.
Conditions:
ST Segment Elevation Myocardial Infarction
Percutaneous Coronary Intervention
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 p...
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 antiplat...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with STEMI undergoing primary PPCI
- Age \> 18 years old
- Exclusion criteria:
- Inability to provide written informed consent
- Known history of prior intracranial bleeding
- On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor) in the prior 10 days
- Known allergies to aspirin, ticagrelor or cangrelor
- On treatment with oral anticoagulant
- Treatment with glycoprotein IIb/IIIa inhibitors
- Fibrinolytics within 24 hours
- Active bleeding
- High risk of bleeding
- Known platelet count \<80x106/mL
- Known hemoglobin \<10 g/dL
- Intubated patients (prior to randomization)
- Known creatinine clearance \<30 mL/minute or on hemodialysis.
- Known severe hepatic dysfunction
- Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection
- Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin.
- Pregnant or lactating females.
Exclusion
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03247738
Start Date
November 20 2017
End Date
December 13 2018
Last Update
September 9 2020
Active Locations (1)
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1
University of Florida
Jacksonville, Florida, United States, 32209