Recruiting

Cangrelor Titration

Sponsor:

University of Florida

Code:

NCT07225842

Conditions

Coronary Arterial Disease (CAD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cangrelor

Study Details

Brief 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.

Conditions

Coronary Arterial Disease (CAD)

Study ID

NCT07225842

Start date

Feb 18, 2026

Status verified date

Sep, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Platelet function-guided cangrelor titration

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.

Interventions

Cangrelor

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.

Primary outcome measure

  • Optimal platelet reactivity [ Time Frame: 2-12 hours ]

Central Contacts and Locations

Central contacts

Luis Ortega-Paz, MD, PhD

904-244 2060Luis.Ortega@jax.ufl.edu

Andrea Burton, MPH, CCRP

904-244-5617Andrea.Burton@jax.ufl.edu

Locations

University of Florida Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Luis Ortega, MD, PhD

904-244-2060Luis.Ortega@jax.ufl.edu

Andrea Burton, MPH, CCRP

904-244-5617andrea.burton@ufhealth.org

Principal Investigator:

Luis Ortega, MD, PhD

More Information

Sponsor

University of Florida

Last update posted

May 5, 2026

Last verified

Sep, 2025

Keywords

  • coronary artery disease
  • cangrelor
  • bridge

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-05-05.