Coronary Arterial Disease (CAD)Phase 4BIRDGE 2NCT07225842
The Bridging Antiplatelet Therapy With Cangrelor 2 Study
A Phase 4 study testing Cangrelor in people with Coronary Arterial Disease (CAD), run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- What is being tested?
- Cangrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2026to Nov 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida Jacksonville
Jacksonville, Florida, 32209
Luis Ortega, MD, PhD, 904-244-2060, Luis.Ortega@jax.ufl.edu
Andrea Burton, MPH, CCRP, 904-244-5617, andrea.burton@ufhealth.org
About this study
Official title: The Bridging Antiplatelet Therapy With Cangrelor 2 (BRIDGE 2) Study: A Pilot Prospective Cohort, Pharmacodynamic Study of Tailored Cangrelor Bridging Dosing Regimens
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.
Read the detailed 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 clinical processes. If the patient's procedure or surgery is re-scheduled to an earlier than expected time, then the study procedures will stop and will not delay the patient's standard of care procedure/surgery. . Patients will be recruited from the inpatient units of the institution and screened by the Cardiology Research staff, who will verify that all candidates meet the inclusion and exclusion criteria.
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.
Blood sampling for PD testing will be performed at different time points: a) baseline (while on 0.75 mcg/kg/min before dose titration); b) between 2 and 12 hours following dose titration; c) daily (at the same time for the second dose) for up to a maximum of 3 samples after dose titration. 8 ml of blood will be obtained at each time point. Patients receiving an oral P2Y12 inhibitor after the cangrelor infusion start will not undergo further PD testing. All other medications will be prescribed as per standard-of-care prescriptions. Study participation will not interfere with standard clinical treatment or delay care. If cangrelor must be stopped per standard of care prior to study completion, then all collected data will be utilized and study participation will end. At the end of the study participation, the patients will follow the medication regimens prescribed by their treating physician per standard of care.
- Conditions
- Coronary Arterial Disease (CAD)
- Being tested
- Cangrelor
- Keywords
- coronary artery disease, cangrelor, bridge
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CangrelorDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cangrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2-12 hours
Secondary outcomes (3)
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
Measured: 24 hours
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
Measured: 48 hours
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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start18 Feb 2026
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominick J Angiolillo, MD, PhD, Study chair, University of Florida College of Medicine - JacksonvilleLuis Ortegra-Paz, MD, PhD, Principal investigator, University of Florida College of Medicine - Jacksonville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225842
- Sponsor's protocol ID
- IRB202500991
- Acronym
- BIRDGE 2
- Status last verified
- Sep 2025
- First submitted
- 6 Nov 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available from the Study Chair upon reasonable request after publication of the main results.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bridging Antiplatelet Therapy With Cangrelor 2 (BRIDGE 2) Study: A Pilot Prospective Cohort, Pharmacodynamic Study of Tailored Cangrelor Bridging Dosing Regimens
- ClinicalTrials.gov ID
- NCT07225842
- Acronym / sponsor ID
- BIRDGE 2 / IRB202500991
- Conditions
- Coronary Arterial Disease (CAD)
- Keywords
- coronary artery disease, cangrelor, bridge
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 clinical processes. If the patient's procedure or surgery is re-scheduled to an earlier than expected time, then the study procedures will stop and will not delay the patient's standard of care procedure/surgery. . Patients will be recruited from the inpatient units of the institution and screened by the Cardiology Research staff, who will verify that all candidates meet the inclusion and exclusion criteria.
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.
Blood sampling for PD testing will be performed at different time points: a) baseline (while on 0.75 mcg/kg/min before dose titration); b) between 2 and 12 hours following dose titration; c) daily (at the same time for the second dose) for up to a maximum of 3 samples after dose titration. 8 ml of blood will be obtained at each time point. Patients receiving an oral P2Y12 inhibitor after the cangrelor infusion start will not undergo further PD testing. All other medications will be prescribed as per standard-of-care prescriptions. Study participation will not interfere with standard clinical treatment or delay care. If cangrelor must be stopped per standard of care prior to study completion, then all collected data will be utilized and study participation will end. At the end of the study participation, the patients will follow the medication regimens prescribed by their treating physician per standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Platelet function-guided cangrelor titration | Experimental | Drug: CangrelorPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CangrelorPatients 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 | Platelet function-guided cangrelor titration |
Primary outcome
Optimal platelet reactivity
Time frame: 2-12 hours
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
3 secondary outcomes
Optimal platelet reactivity
Time frame: 24 hours
Optimal platelet reactivity
Time frame: 48 hours
Optimal platelet reactivity
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. Data will be available from the Study Chair upon reasonable request after publication of the main results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dominick J Angiolillo, MD, PhD study chair
University of Florida College of Medicine - Jacksonville
Luis Ortegra-Paz, MD, PhD principal investigator
University of Florida College of Medicine - Jacksonville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cangrelor in people with Coronary Arterial Disease (CAD), run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis Ortega-Paz, MD, PhD (904-244 2060, Luis.Ortega@jax.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal platelet reactivity (time frame: 2-12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.