Cangrelor for Coronary Artery Disease
(BIRDGE 2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the drug cangrelor to determine if adjusting its dose based on platelet function tests (which assess how well blood cells involved in clotting work) benefits individuals with coronary artery disease, a condition affecting blood flow to the heart. Researchers aim to compare customized dosing with standard dosing to identify the best method for managing platelet reactivity. This trial suits those already using cangrelor at a standard rate for at least two hours as part of their regular care. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
The trial requires that you have not taken any oral P2Y12 inhibitors, oral anticoagulants, or glycoprotein IIb/IIIa inhibitors within 48 hours before participating.
What is the safety track record for cangrelor?
Research has shown that cangrelor is generally safe for people with coronary artery disease. Studies have found that patients tolerate it well during procedures like percutaneous coronary intervention (PCI), which treats blocked arteries. These studies confirmed cangrelor's safety, with few side effects reported.
Cangrelor, administered through an IV, helps prevent blood clots during heart procedures. Its approval in Europe for this use boosts confidence in its safety. Reports indicate that patients experienced few complications when cangrelor was used, making it a reliable choice for heart procedures.
While no treatment is without side effects, evidence suggests that cangrelor is a safe option for managing coronary artery disease in clinical settings.12345Why are researchers enthusiastic about this study treatment?
Cangrelor is unique because it offers a rapid, intravenous option for managing coronary artery disease, unlike most standard oral antiplatelet therapies like clopidogrel or ticagrelor. Researchers are excited about its potential for dynamic dose adjustment based on platelet reactivity units (PRU), which can optimize the treatment for individual patients in real-time. This personalized approach could lead to more effective prevention of blood clots with fewer side effects, offering a significant advancement over the one-size-fits-all dosing of current oral medications.
What is the effectiveness track record for cangrelor in treating coronary artery disease?
Research shows that cangrelor lowers the risk of serious heart problems and blood clots in stents for people with coronary artery disease (CAD). Studies found that patients receiving cangrelor during procedures like percutaneous coronary intervention (PCI) had a 19% lower chance of negative outcomes compared to those who did not. In this trial, participants will undergo platelet function-guided cangrelor titration to optimize dosing. Cangrelor is particularly beneficial for patients needing quick, short-term prevention of blood cells clumping together. It is approved for reducing clot-related heart issues, making it a reliable option in medical settings.12678
Who Is on the Research Team?
Dominick J Angiolillo, MD, PhD
Principal Investigator
University of Florida College of Medicine - Jacksonville
Luis Ortegra-Paz, MD, PhD
Principal Investigator
University of Florida College of Medicine - Jacksonville
Are You a Good Fit for This Trial?
This trial is for adults (18 or older) with heart disease who are already receiving cangrelor as a bridge therapy. Participants must not have allergies to cangrelor or certain ingredients, can't be pregnant or breastfeeding, and shouldn't have taken specific blood thinners recently.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cangrelor infusion with dose titration based on PRU levels
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cangrelor
Trial Overview
The study compares two ways of giving the drug cangrelor: adjusting the dose based on platelet tests versus using a standard fixed dose. The goal is to see which method keeps blood platelets in an optimal range before surgery.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
Citations
Efficacy and safety of cangrelor for patients with coronary ...
Conclusions: Intravenous administration of cangrelor is benefit to reduce risk of MACE and stent thrombosis in patients with CAD excepting for increased minor ...
Cangrelor: Clinical Data, Contemporary Use, and Future ...
Cangrelor was approved by European Medical Agency for the reduction of thrombotic cardiovascular events in patients with CAD undergoing PCI who ...
Use of Cangrelor for Patients Undergoing Coronary Artery ...
Patients treated with cangrelor were more likely to have PCI during hospitalization (P < 0.001) and less likely to have radial access (P = 0.005) ...
Comparative effectiveness of Cangrelor in patients with ...
Cangrelor group showed higher rate of femoral access and higher stent number and total stent length, despite a lower quote of multivessel ...
Effect of cangrelor on periprocedural outcomes in ...
FINDINGS: Cangrelor reduced the odds of the primary outcome by 19% (3.8% for cangrelor vs 4.7% for control; odds ratio [OR] 0.81, 95% CI 0.71- ...
Safety of cangrelor and transition to oral P2Y 12 inhibitors in ...
The use of cangrelor in ACS patients undergoing PCI and the transition strategy to P2Y 12 inhibitors are confirmed as safe and effective in daily practice.
TCT-238 Safety and Efficacy of Cangrelor
A nationwide retrospective assessment of the use of cangrelor in mainly ACS patients receiving PCI, shows safe and effective index hospitalization results.
Feasibility and safety of cangrelor in patients with suboptimal ...
Cangrelor showed to have an acceptable safety profile with a low rate of short-term ischaemic outcome in patients with ACS and stable CAD undergoing PCI in ...
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