The Bridging Antiplatelet Therapy With Cangrelor 2 (BRIDGE 2) Study: A Pilot Prospective Cohort, Pharmacodynamic Study of Tailored Cangrelor Bridging Dosing Regimens
University of Florida
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugCangrelor
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.
Location
- University of Florida JacksonvilleJacksonville, Florida