[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07225842":3,"trial-entities:NCT07225842":98,"trial-summary:NCT07225842":102},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":58,"locations":61,"central_contacts":83,"overall_officials":89,"references":96,"see_also_links":97},"NCT07225842","IRB202500991","The Bridging Antiplatelet Therapy With Cangrelor 2 Study","The Bridging Antiplatelet Therapy With Cangrelor 2 (BRIDGE 2) Study: A Pilot Prospective Cohort, Pharmacodynamic Study of Tailored Cangrelor Bridging Dosing Regimens","RECRUITING","2027-11","2025-09","2026-05-05","2026-02-18","University of Florida","OTHER",true,"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\u002Fkg\u002Fmin (standard-dose infusion) for bridging.","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\u002Fkg\u002Fmin (standard-dose infusion).The typical wait time for the patient's aforementioned procedure\u002Fsurgery 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\u002Fsurgery. . 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.\n\nAfter 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\u002Fkg\u002Fmin, while patients with PRU levels \\>208 will undergo dose increase to 1.0 mcg\u002Fkg\u002Fmin. 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\u002Fkg\u002Fmin up to a maximum of 1.5 mcg\u002Fkg\u002Fmin until a PRU below 208 is achieved, while patients with PRU levels \\\u003C85 will undergo dose reduction to 0.25 mcg\u002Fkg\u002Fmin, being the lowest possible administration rate allowed during the study period.\n\nBlood sampling for PD testing will be performed at different time points: a) baseline (while on 0.75 mcg\u002Fkg\u002Fmin 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.",[19],"Coronary Arterial Disease (CAD)",[21,22,23],"coronary artery disease","cangrelor","bridge","INTERVENTIONAL","TREATMENT",[27],"PHASE4",{"count":29,"type":30},50,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Cangrelor","Patients with PRU levels ≤208 will undergo cangrelor dose reduction to 0.50 mcg\u002Fkg\u002Fmin, while patients with PRU levels \\>208 will undergo dose increase to 1.0 mcg\u002Fkg\u002Fmin. 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\u002Fkg\u002Fmin up to a maximum of 1.5 mcg\u002Fkg\u002Fmin until a PRU below 208 is achieved, while patients with PRU levels \\\u003C85 will undergo dose reduction to 0.25 mcg\u002Fkg\u002Fmin, 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\u002Fkg\u002Fmin 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.",[37],"Platelet function-guided cangrelor titration",[39],{"measure":40,"description":41,"timeFrame":42},"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\u002Fkg\u002Fmin (standard-dose infusion) for bridging","2-12 hours",[44,46,48],{"measure":40,"description":41,"timeFrame":45},"24 hours",{"measure":40,"description":41,"timeFrame":47},"48 hours",{"measure":40,"description":41,"timeFrame":49},"72 hours","ALL","18 Years",null,false,{"inclusion":55,"exclusion":56,"raw_text":57},[],[],"Inclusion Criteria:\n\n1. Any patient receiving bridging with standard-dose cangrelor infusion rate of 0.75 mcg\u002FKg\u002Fmin for at least two hours as part of their standard of care.\n2. Age ≥18 years\n3. Provide written informed consent.\n\nExclusion Criteria:\n\n1. Need for urgent surgery\n2. Confirmed or suspected pregnancy (in woman of child-bearing potential) or lactating females\n3. Exposure to any oral P2Y12 inhibitor, oral anticoagulant or glycoprotein IIb\u002FIIIa inhibitor within 48 hours.\n4. Known allergy, and hypersensitivity, or contraindication to cangrelor, mannitol, sorbitol, or microcrystalline cellulose",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":63,"status":8,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":80},"University of Florida Jacksonville","Jacksonville","Florida","32209","United States",[69,74,78],{"name":70,"role":71,"phone":72,"email":73},"Luis Ortega, MD, PhD","CONTACT","904-244-2060","Luis.Ortega@jax.ufl.edu",{"name":75,"role":71,"phone":76,"email":77},"Andrea Burton, MPH, CCRP","904-244-5617","andrea.burton@ufhealth.org",{"name":70,"role":79},"PRINCIPAL_INVESTIGATOR",{"lat":81,"lon":82},30.33218,-81.65565,[84,87],{"name":85,"role":71,"phone":86,"email":73},"Luis Ortega-Paz, MD, PhD","904-244 2060",{"name":75,"role":71,"phone":76,"email":88},"Andrea.Burton@jax.ufl.edu",[90,94],{"name":91,"affiliation":92,"role":93},"Dominick J Angiolillo, MD, PhD","University of Florida College of Medicine - Jacksonville","STUDY_CHAIR",{"name":95,"affiliation":92,"role":79},"Luis Ortegra-Paz, MD, PhD",[],[],{"nct_id":4,"conditions":99,"biomarkers":101},[100],"Coronary Artery Disease",[],{"nct_id":4,"found":15,"summary":103,"prompt_version":113},{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is a single-arm, open-label study involving 50 participants. It is not specified if there are different phases of the study.","completed","Bridging Antiplatelet Therapy With Cangrelor 2 Study for Coronary Artery Disease","This study is looking at how to best use a medication called cangrelor to prevent blood clots in people with coronary artery disease (CAD). Cangrelor is given as a bridge when patients need to temporarily stop other anti-clotting medicines before a heart procedure. The study will test if adjusting the dose of cangrelor based on your platelet reactivity (how sticky your platelets are) works better than a standard dose. We want to see if this personalized approach can help more patients reach an \"optimal platelet reactivity\" level, which is a specific range (PRU levels between 85 and 208). You might be able to join if you are at least 18 years old, have CAD, and are already receiving cangrelor before a heart procedure. The study aims to enroll 50 participants and is currently unclear on its recruitment status.","Your platelet reactivity will be assessed 2 to 12 hours after any dose adjustments.",138,"If you join, you will have blood samples taken to measure your platelet reactivity. Based on these results, your cangrelor dose may be adjusted, and more blood samples will be taken 2 to 12 hours later.","Not stated in the trial record.",[34],"v2"]