The Bridging Antiplatelet Therapy With Cangrelor 2 Study

NCT07225842 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB202500991
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Keywords

coronary artery disease; cangrelor; bridge

Outcome Measures

Primary Outcomes (1)

• Optimal platelet reactivity

  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

  2-12 hours

Secondary Outcomes (3)

• Optimal platelet reactivity

  24 hours

• Optimal platelet reactivity

  48 hours

• Optimal platelet reactivity

  72 hours

Study Arms (1)

Platelet function-guided cangrelor titration

EXPERIMENTAL

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.

Drug: Cangrelor

Interventions

Cangrelor DRUG

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.

Platelet function-guided cangrelor titration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age ≥18 years
• Provide written informed consent.

You may not qualify if:

• Need for urgent surgery
• Confirmed or suspected pregnancy (in woman of child-bearing potential) or lactating females
• Exposure to any oral P2Y12 inhibitor, oral anticoagulant or glycoprotein IIb/IIIa inhibitor within 48 hours.
• Known allergy, and hypersensitivity, or contraindication to cangrelor, mannitol, sorbitol, or microcrystalline cellulose

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

cangrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Dominick J Angiolillo, MD, PhD

  University of Florida College of Medicine - Jacksonville

  STUDY CHAIR

• Luis Ortegra-Paz, MD, PhD

  University of Florida College of Medicine - Jacksonville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Ortega-Paz, MD, PhD

CONTACT

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

Andrea Burton, MPH, CCRP

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After providing informed consent, eligible patients will undergo a baseline evaluation of PRU levels by means of the VerifyNow system. The research study team will perform the PRU assessment in the cardiovascular research lab as this is considered a research only assessment and is not currently performed as standard of care. 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.

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: November 10, 2025
• Study Start: February 18, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE

Locations

US (1)