Dosing and administration guide for kengreal cangrelor. Kengreal cangrelor dose, indications, adverse effects. Cangrelor versus standard therapy to achieve optimal management of. It found usefulness of cangrelor in patients getting cardiac stents. Cangrelor kengreal is a prescription drug used to reduce the risk of heart attack during cardiology procedures. Effect of cangrelor on periprocedural outcomes in percutaneous coronary interventions.
Bridging antiplatelet therapy with the intravenous agent cangrelor. This was a singlecenter study, conducted in janfeb 20. Mahaffey and harrington revisit studies of cangrelor use. Harrington ra, et al, 2009 champion pci trial study design. The bridge study assessed cangrelor as a replacement for oral p2y 12 inhibitors in patients awaiting cabg surgery and demonstrated that cangrelor maintained platelet inhibition during the preoperative period and enabled a rapid return to baseline platelet function upon cessation of the infusion. Fda committee recommends against approval of medicines.
Within 2 minutes following 30 mcgkg iv bolus followed by 4 mcgkgmin iv infusion. Studies on cangrelor have failed to demonstrate a significantly increased bleeding risk. Cangrelor is an antiplatelet drug, that is, a drug that inhibits the ability of platelets to clump together as part of a blood clot. Cangrelor was associated with a reduction in pri values during the overall study time course in patients reloaded with 30 mg p 0. Bridging antiplatelet therapy with cangrelor in patients undergoing. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. A panel of fda advisers reversed its earlier derision and voted in favor of the medicines companys longdelayed blood thinner, spelling a. Additional trials may be necessary to further define. Stage i was an openlabel, dosefinding phase of the study aimed to identify the dose of cangrelor that achieved a desired antiplatelet effect after. Cangrelor is an intravenous, nonthienopyridine antagonist of the p2y12 receptor with a rapid, potent, predictable, and quickly reversible effect. For the primary endpoints, the pooled analysis shows that the ischemic benefit of cangrelor over clopidogrel exceeded the bleeding rate in the gpinaive study patients.
An advantage cangrelor provides over oral p2y12 inhibitors such as prasugrel, ticagrelor, and clopidogrel is that it is an active drug not requiring. Associate chief of cardiology director of cardiovascular research and. Maintenance of platelet inhibition with cangrelor after. Cangrelor franchi wiley online books wiley online library. It is not approved yet for marketing, but only for clinical investigations.
The maintenance of platelet inhibition with cangrelor after discontinuation of thienopyridines in patients undergoing surgery bridge study is currently investigating whether cangrelor is a safe alternative for bridging patients during the pre and postsurgical period of risk. However, the prognostic significance of these endpoints, periprocedural mi in particular, is the subject of ongoing controversy. Randomized, doubleblind, placebocontrolled, doubledummy, multicenter study study funding. Cangrelor proposed as bridge to surgery cardiobrief. Although not all of these side effects may occur, if they do occur they may need medical attention. Jan 30, 2018 outside of the champion program, cangrelor has also been studied in the phase ii clinical trial bridge maintenance of platelet inhibition with cangrelor after discontinuation of thienopyridines in patients undergoing surgery. Results efficacy significantly more patients on cangrelor than placebo had low levels of platelet reactivity throughout the entire infusion the rate of the primary end point during the infusion was 98. Performance of neuraxial blockade procedures is not recommended during cangrelor use due to the potential risk of spinal hematoma. Those studies ended prematurely in 2009 after an interim analysis suggested cangrelor was not superior to other antiplatelet medications.
The study included all 3 of the champion trials, including the aforementioned phoenix, as well as pci and platform, for a total of about 25,000 patients. In the randomized phase, a greater proportion of patients treated with cangrelor had low levels of platelet reactivity throughout the entire treatment period compared with placebo primary end point, pru study is an important personal decision. P2y12 platelet inhibitor that blocks adpinduced platelet activation and aggregation. Use of intravenous antiplatelet agents cangrelor and. Cangrelor ticagrelor transition study study results. Fda panel rejects cangrelor for both pci, bridging. Cangrelor is an agent that prevents platelets from proliferating during the pci procedure. Christian hamm at the european society of cardiology congress, amsterdam, holland, september 3, 20. The bridge study, for short term use prior to surgery, continues. We compare the antiplatelet effect and bleeding risk of intravenous cangrelor to oral p2y12inhibitors in patients with mi receiving th in a prospective comparison of two matched patient cohorts. What is the effect of cangrelor, an intravenous, reversible p2y 12 platelet inhibitor, for bridging thienopyridinetreated patients to.
The medicines companys cangrelor bridge trial published. Jun 22, 2015 kengreal cangrelor is an intravenous p2y 12 platelet inhibitor indicated for use in patients undergoing percutaneous coronary intervention pci to reduce the risk of periprocedural thrombotic events. Cangrelor arc69931mx is approved as an adjunct to percutaneous coronary intervention pci to reduce the risk of periprocedural myocardial infarction mi, repeat coronary revascularization, and stent thrombosis in patients who have not been treated with a p2y 12 platelet inhibitor and are not being given a glycoprotein iibiiia inhibitor. Future large, clinical, outcomebased studies may be warranted to elucidate a role for cangrelor as a bridge to cardiac and noncardiac surgeries.
Oct 07, 2008 the purpose of this study is to demonstrate that patients receiving cangrelor infusion before coronary artery bypass grafting have an acceptable safety profile and can undergo surgery without excessive bleeding perioperatively. Use of intravenous antiplatelet agents cangrelor and gpiib. Bridging antiplatelet therapy with cangrelor in patients undergoing cardiac. Indicates that the study sponsor or investigator has submitted summary results information for a clinical study to clinicaltrials. Outside of the champion program, cangrelor has also been studied in the phase ii clinical trial bridge maintenance of platelet inhibition with cangrelor after discontinuation of thienopyridines in patients undergoing surgery. In this singlecenter retrospective cohort study, we examined practice patterns, indications for use, and clinical events in cangrelor recipients identified by inhospital pharmacy records at a large, tertiary care institution. Kengreal cangrelor dosing, indications, interactions. Log in to print or send this list to your patient and. Cangrelor proposed as bridge to surgery cardioexchange. Kengreal cangrelor for injection is a p2y 12 platelet inhibitor indicated as an adjunct to percutaneous coronary intervention pci to reduce the risk of periprocedural myocardial infarction mi, repeat coronary revascularization, and stent thrombosis st in patients who have not been treated with a p2y 12 platelet inhibitor and are not.
Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. Pci or for antiplatelet bridging in patients requiring major surgery. Pdf bridging antiplatelet therapy with cangrelor in patients. Cangrelor last updated on april 26, 2020 2020 memorial sloan kettering cancer center. When possible, discontinue use of cangrelor 1 hour prior to labor, delivery, or neuraxial blockade.
It belongs to a class of drugs called p2y12 inhibitors. Trial enrollment was terminated after a second interim analysis, because it was decided that cangrelor was not superior to placebo. Log in to print or send this list to your patient and save lists of resources you use frequently. Cangrelor prevents blood clots by reversibly binding to the p2y12 receptor on platelets, preventing adenosine diphosphate adp from activating platelets.
Pdf bridging antiplatelet therapy with cangrelor in. Side effects include bleeding, allergic reactions, and shortness of breath. Intravenous cangrelor as a periprocedural bridge with applied uses. The dose of cangrelor determined in 10 patients in the openlabel stage was 0. To test this strategy, the bridge investigators randomized 210 acs or stent patients awaiting cabg and taking a thienopyridine to receive either cangrelor or placebo for at. Cangrelor is a direct p2y 12 platelet receptor antagonist that blocks adenosine diphosphate induced platelet activation and aggregation. Study defined excessive cabg surgeryrelated bleeding occurred in a total of 22 patients and was not significantly different between patients randomly assigned to receive cangrelor 11. A reference point was chosen for comparison and designated the first draw during the cangrelor infusion 0.
Cangrelor has been studied in a broad population intended to receive pci in the champion program, where it was compared with different clopidogrel regimens. In the randomized phase, a greater proportion of patients treated with cangrelor had low levels of platelet reactivity throughout the entire treatment period compared with placebo primary end point, pru nov 15, 2011 bridge is a prospective, randomized doubleblind, placebocontrolled, multicenter trial in 210 patients with acute coronary syndrome acs or treated with a coronary stent on a thienopyridine. In the current trial we hypothesized that cangrelor may be a safe and effective drug to bridge patients from irreversible platelet p2y12 inhibitors. At 48 hours, cangrelor reduced the combined risk of death, mi, ischemiadriven revascularization, or stent thrombosis primary efficacy outcome by 19% compared with clopidogrel, and this. Patients in the cangrelor group received clopidogrel 600 mg. Drug interactions, dosage, and pregnancy and breastfeeding safety are provided. Talk with your doctor and family members or friends about deciding to join a study. Bridge is a prospective, randomized, doubleblind, placebocontrolled multicenter trial which evaluated cangrelor or placebo in 210 patients with an acute coronary syndrome acs or treated with a coronary stent and receiving a thienopryidine awaiting coronary artery bypass graft cabg surgery. Kengrexal 50 mg powder for concentrate for solution for. Cangrelor ticagrelor transition study full text view. Please see reverse for full important safety information and accompanying full prescribing information.
The champion phoenix trial was a randomized study of over 11,000 patients published in 20. In 2011, the medicines company conducted a bridge trial, a placebo controlled study of cangrelor. In combination with aspirin for the reduction of thrombotic cardiovascular events in patients with coronary artery disease undergoing percutaneous coronary intervention. Cangrelor is an intravenous, directacting, reversible p2y12 inhibitor for patients undergoing percutaneous coronary intervention pci who have not been yet treated by oral p2y12 inhibitors. Feb 12, 2020 the primary clinical evidence for the efficacy of cangrelor is derived from champion phoenix, a randomised, doubleblind study comparing cangrelor n5,472 to clopidogrel n5,470, both given in combination with aspirin and other standard therapy, including unfractionated heparin 78%, bivalirudin 23%, lmwh 14% or fondaparinux 2. The bridge study assessed cangrelor as a replacement for oral p2y 12 inhibitors in patients awaiting cabg surgery and demonstrated that cangrelor maintained platelet inhibition during the preoperative period and enabled a rapid return to baseline platelet function upon. Kengreal is the only iv p2ypl12 atelet inhibitor indicated as an adjunct to pci. Platelet inhibition is the main goal of ancillary pharmacologic therapy during percutaneous coronary interventions pci. In phoenix, there were more bleeds with cangrelor, depending on the definition used, although the study s primary safety end point, gusto severe noncabg or severemoderate bleeding, did not.
Thienopyridines and ticagrelor are oral drugs developed for this purpose. Cangrelor infusion provides a level of platelet inhibition equivalent to that expected to be maintained if oral thienopyridine was not discontinued study, showing that the intravenous p2y12 receptor antagonist cangrelor the medicines company could represent an effective bridging. The study, published in the february 2012 issue of the american heart journal, used data from the two champion cangrelor versus standard therapy to achieve optimal management of platelet inhibition studies. Dual antiplatelet therapy is the standard of care for patients with myocardial infarction mi, who have been resuscitated and treated with therapeutic hypothermia th. All patients were awaiting coronary artery bypass grafting cabg to receive either cangrelor or placebo after an initial openlabel, dosefinding phase. Cangrelor was approved by our hospital formulary in september 2015 and first used in november 2015. To evaluate the use of cangrelor, an iv, reversible p2y12 platelet inhibitor, for bridging thienopyridinetreated patients awaiting cabg hypothesis. Cangrelor use during labor and obstetric delivery may increase the risk for maternal bleeding and hemorrhage. The purpose of this study was to study the pharmacodynamic characteristics of transition from iv cangrelor to oral ticagrelor, and ticagrelor to cangrelor in patients with coronary artery disease. The goal of the trial was to evaluate treatment with cangrelor. Cangrelor, a reversible intravenous p2y12 receptor inhibitor, has been shown. Maintenance of platelet inhibition with cangrelor bridge. Cangrelor has clearly reduced periprocedural mi, but in a metaanalysis of 15,581 patients, periprocedural mi occurring in 32.
Cangrelor intravenous route side effects mayo clinic. Cangrelor was studied in two largescale phase 3 studies that were both ended early following a. Kengreal cangrelor for injection is contraindicated in patients with significant active bleeding. Bridging antiplatelet therapy with cangrelor in patients. Cangrelor is a rapidacting, reversible, nonthienopyridine adenosine triphosphate atp analogue that is administered intravenously iv to block the adp receptor p2y 12. Verifynow was used specifically to guide cangrelor dosing in the trials. Sep 02, 2019 data from a multicenter, randomized, double blind study support the use of cangrelor following thienopyridine discontinuation in patients awaiting nonemergent coronary artery bypass graft surgery. As a potent and reversible platelet inhibitor, cangrelor has been proposed for use in a bridging strategy for patients scheduled for surgery who are currently taking clopidogrel or another thienopyridine. In the current trial we hypothesized that cangrelor may be a safe and effective drug to bridge patients from irreversible platelet p2y12 inhibitors to open heart. Of note, ischemic endpoints were low in both the cangrelor and placebo groups angiolillo 2012. Bhatt dl, et al, 2009 champion platform trial 9 study design.302 771 1440 373 172 915 1207 554 1230 778 1307 49 641 362 1030 954 455 1259 804 459 783 75 1254 44 1334 92 1439 981 588 25 71 795 1091 1159 454 1036 783 269 206 407 667 589 86 1472 72