Platelet Inhibition With Cangrelor and Crushed Ticagrelor in STEMI

• Status: Completed
• Trial end date: 2018-12-13
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: University of Florida
• Collaborator: Chiesi Farmaceutici S.p.A.
• Treatments: Cangrelor; Ticagrelor

Criteria

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.