Patients a least 18 years of age on DAPT per standard of care who are planned to undergo non deferrable cardiac and non cardiac surgery which will require discontinuation of a P2Y12 inhibitor. Subjects with stent implantation within 12 months of an ACS and within 6 months of elective stent implantation for stable CAD, or subjects subjected to elective PCI within the previous 12 months if still in DAPT because considered high-risk thrombotic will be included. MedDRA version: 20.0 Level: HLGT Cla
Conditions
Interventions
Trade Name: Kengrexal 50 mg polvere per concentrato per soluzione per iniezione/infusione
Product Name: Cangrelor
Product Code: [CANGRELOR. Si segnala che il codice ATC di seguit
Pharmaceutical Form:
Sponsors
AZIENDA SANITARIA OSPEDALIERA S.CROCE E CARLE CUNEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent before initiation of any study related procedures; 2. be = 18 years of age; 3. have received any dose of a P2Y12 inhibitor (clopidogrel, ticlopidine, prasugrel, or ticagrelor) at any dose within at least 48 hours prior to randomization; 4. patients undergoing non deferrable cardiac or non cardiac surgery which requires discontinuation of P2Y12 inhibitor due to a significant bleeding risk. 5. Female subject of potential child-bearing should have a negative pregnancy test (preferably serum hCG pregnancy test) at screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. Active bleeding with evident contraindications to DAPT 2. Patients requiring oral anticoagulant therapy 3. PCI within 1 month 4. Intracranial neoplasm or history of intracranial surgery 5. History of bleeding diathesis 6. Thrombocytopenia (platelet count of less than 100,000/µL) 7. Known International Normalized Ratio (INR) greater than 1.5 at screening. 8. Requirement for dialysis treatment (hemodialysis or peritoneal) 9. Estimated Glomeular filtration rate eGFR <30 ml/min 10. Administration of abciximab within 24 hours of randomization or administration of eptifibitide or tirofiban within 12 hours of randomization 11. Plans to continue oral anticoagulant or P2Y12 inhibitors or cangrelor in the pre-operative period 12. Refusal to receive blood transfusion 13. Receipt of fibrinolytic therapy in the 12 hours preceding randomization 14. Allergy, hypersensitivity, or contraindication to cangrelor, mannitol, sorbitol, or microcrystalline cellulose 15. High likelihood of being unavailable for follow-up 16. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization 17. Confirmed of suspected pregnancy (if woman of child-bearing potential) or lactating females confirmed. Pregnancy status must be confirmed by serum or urine test (preferably by a serum hCG pregnancy test) 18. Any disease or condition which, in the judgment of the investigator, would place the patient at undue risk by being enrolled in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy objective of this study is to demonstrate that a cangrelor infusion will maintain levels of residual platelet reactivity (PRU < 208) as measured by Accriva VerifyNow® P2Y12 assay. The main safety objective is to demonstrate that patients receiving cangrelor infusion before cardiac and non cardiac surgery have an acceptable safety profile and can undergo surgery without excessive bleeding peri-operatively.;Secondary Objective: The absence of excessive surgery-related bleeding, defined as the occurrence of bleeding events of Bleeding Academic Research Consortium (BARC)25 grade = 3 in patients undergoing non cardiac surgery and BARC = 4 in patients undergoing cardiac surgery or with the need for re-intervention within 24 hours of discontinuation of the study drug. In addition, ischemic endpoints (death, myocardial infarction, defined and probable stent thrombosis) and hemorrhages (as previously defined) will be evaluated up to a 30-day follow-up and detailed analysis of platelet reactivity data in the different phases of the period surgical.;Primary end point(s): The primary endpoint is the percentage of patients with PRU < 208 for all samples assessed during study drug infusion prior to surgery as determined by VerifyNow® P2Y12 point of care assay measured during study drug infusion prior to surgery.;Timepoint(s) of evaluation of this end point: The study drug will be measured during study drug infusion prior to surgery. | — |
Countries
European Union, Italy
Contacts
Public ContactClinical Operation
Advice Pharma Group Srl
Outcome results
None listed