University of Florida
The primary aim of this study is to determine rates of patients with optimal platelet reactivity range, defined as PRU levels between 85 and 208, when using a (PFT)-guided titration of cangrelor infusion rate (cangrelor titration) compared to 0.75 mcg/kg/min (standard-dose infusion) for bridging.
The proposed investigation is a prospective, single-arm, open-label PD study in patients that are admitted to UF Health Jacksonville with established coronary artery disease. These patients will be awaiting a coronary intervention in the cardiac cath lab or a coronary artery bypass graft in the operating room and have received at least a two-hour infusion of cangrelor as standard of care for bridging at 0.75 mcg/kg/min (standard-dose infusion).The typical wait time for the patient's aforementioned procedure/surgery is 5 days or more and the study schedule will not interfere with the typical cl…
Inclusion Criteria: 1. Any patient receiving bridging with standard-dose cangrelor infusion rate of 0.75 mcg/Kg/min for at least two hours as part of their standard of care. 2. Age ≥18 years 3. Provide written informed consent. Exclusion Criteria: 1. Need for urgent surgery 2. Confirmed or suspected pregnancy (in woman of child-bearing potential) or lactating females 3. Exposure to any oral P2Y12 inhibitor, oral anticoagulant or glycoprotein IIb/IIIa inhibitor within 48 hours. 4. Known allergy, and hypersensitivity, or contraindication to cangrelor, mannitol, sorbitol, or microcrystalline c…
Patients with PRU levels ≤208 will undergo cangrelor dose reduction to 0.50 mcg/kg/min, while patients with PRU levels \>208 will undergo dose increase to 1.0 mcg/kg/min. At 2 to 12 hours after dose titration, blood samples will be collected for further PD assessment of platelet reactivity. Patients with PRU values \>208 will undergo dose increase by 0.25 mc/kg/min up to a maximum of 1.5 mcg/kg/min until a PRU below 208 is achieved, while patients with PRU levels \<85 will undergo dose reduction to 0.25 mcg/kg/min, being the lowest possible administration rate allowed during the study period. Titration will be performed at 3 time points: baseline (while on 0.75 mcg/kg/min before dose titration); between 2 and 12 hours following dose titration; daily (at the same time for the second dose) for up to a maximum of 3 samples after dose titration.
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