Platelet Aggregation Inhibitors
Conditions
Keywords
aNtiplatElet Therapy, cangrelor, randomized, DAPT
Brief summary
The MONET BRIDGE study is designed to assess the use of cangrelor as a platelet-inhibiting bridge for patients who discontinue DAPT before cardiac and non cardiac surgery within 12 months from coronary stent implantation. It seeks to determine if initiation of a prolonged cangrelor infusion maintains effective platelet inhibition after discontinuation of P2Y12 and whether a cangrelor infusion before cardiac and non cardiac procedures is safe.
Detailed description
This will be a randomized, double-blind, placebo-controlled study enrolling patients with coronary stent, still on DAPT, undergoing cardiac and non cardiac surgery within 12 months from coronary stent implantation. The MONET BRIDGE study is designed to assess the use of cangrelor as a platelet-inhibiting bridge for patients who discontinue DAPT before cardiac and non cardiac surgery within 12 months from coronary stent implantation. It seeks to determine if initiation of a prolonged cangrelor infusion maintains effective platelet inhibition after discontinuation of P2Y12 and whether a cangrelor infusion before cardiac and non cardiac procedures is safe. 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.
Interventions
DRUGCangrelor
Cangrelor is an intravenous analog of adenosine triphospate with a potent, selective and specific affinity for P2Y12 receptors.
Sponsors
Ospedale Santa Croce-Carle Cuneo
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
1. Confirmed of suspected pregnancy (if woman of child-bearing potential) or lactating females 2. Active bleeding with evident contraindications to DAPT 3. Patients requiring oral anticoagulant therapy 4. PCI within 1 month 5. Intracranial neoplasm or history of intracranial surgery 6. History of bleeding diathesis 7. Thrombocytopenia (platelet count of less than 100,000/µL) 8. Known International Normalized Ratio (INR) greater than 1.5 at screening. 9. Requirement for dialysis treatment (hemodialysis or peritoneal) 10. Estimated Glomeular filtration rate eGFR \<30 ml/min 11. Administration of abciximab within 24 hours of randomization or administration of eptifibitide or tirofiban within 12 hours of randomization 12. Plans to continue oral anticoagulant or P2Y12 inhibitors or cangrelor in the pre-operative period 13. Refusal to receive blood transfusion 14. Receipt of fibrinolytic therapy in the 12 hours preceding randomization 15. Allergy, hypersensitivity, or contraindication to cangrelor, mannitol, sorbitol, or microcrystalline cellulose 16. High likelihood of being unavailable for follow-up 17. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization 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 | Description |
|---|---|---|
| LEVEL OF RESIDUAL PLATELET REACTIVITY | 1-2 hours | Accriva VerifyNow P2Y12 assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ischemic and hemorrhagic endpoints | 30 days | Bleeding Academic Research Consortium (BARC) grade \> 3 |
Outcome results
None listed