Cangrelor dose adjustment using platelet testing for patients awaiting coronary procedures
The Bridging Antiplatelet Therapy With Cangrelor 2 (BRIDGE 2) Study: A Pilot Prospective Cohort, Pharmacodynamic Study of Tailored Cangrelor Bridging Dosing Regimens
PHASE4 · University of Florida · NCT07225842
This trial tests whether adjusting the cangrelor infusion based on platelet-function testing keeps platelet reactivity in the target range for adults with coronary artery disease awaiting coronary procedures.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT07225842 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm, open-label pharmacodynamic study at UF Health Jacksonville enrolling inpatients with established coronary artery disease who are being bridged with cangrelor. After at least two hours on the standard 0.75 mcg/kg/min infusion, participants receive a baseline PRU measurement with the VerifyNow system and the infusion is titrated: reduced to 0.50 mcg/kg/min if PRU ≤208 or increased to 1.0 mcg/kg/min if PRU >208, aiming for a PRU range of 85–208. Study procedures are research-only and performed without delaying the planned coronary intervention or CABG; if the procedure is moved earlier the study procedures stop. Enrollment and screening are performed by the cardiology research staff on the inpatient units.
Who should consider this trial
Good fit: Adults (≥18) with coronary artery disease who have been on standard-dose cangrelor (0.75 mcg/kg/min) for at least two hours while awaiting coronary intervention or CABG and who can provide informed consent are ideal candidates.
Not a fit: Patients needing urgent surgery, pregnant or lactating women, those recently exposed to oral P2Y12 inhibitors or anticoagulants, or with known contraindications to cangrelor are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could keep platelet reactivity within the therapeutic window during pre-procedure bridging and may lower the risk of clotting or bleeding around coronary procedures.
How similar studies have performed: Previous trials have shown cangrelor can maintain platelet inhibition during bridging, but platelet-function-test–guided dose titration is a newer strategy with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 cellulose
Where this trial is running
Jacksonville, Florida
- University of Florida Jacksonville — Jacksonville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Luis Ortegra-Paz, MD, PhD — University of Florida College of Medicine - Jacksonville
- Study coordinator: Luis Ortega-Paz, MD, PhD
- Email: Luis.Ortega@jax.ufl.edu
- Phone: 904-244 2060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Arterial Disease, coronary artery disease, cangrelor, bridge