Clinical trial NCT03862651: Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery (MONET BRIDGE)
Official title: MONET BRIDGE(Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery) - (Mantenimento Della Terapia Antiaggregante Nei Pazienti Portatori di Stent Coronarico Candidati a Chirurgia)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Platelet Aggregation Inhibitors
Keywords: aNtiplatElet Therapy
cangrelor
randomized
DAPT
Lead sponsor: Ospedale Santa Croce-Carle Cuneo
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

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

Primary outcomes:
measure: LEVEL OF RESIDUAL PLATELET REACTIVITY
timeFrame: 1-2 hours
Secondary outcomes:
measure: ischemic and hemorrhagic endpoints
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
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citation: Albaladejo P, Marret E, Samama CM, Collet JP, Abhay K, Loutrel O, Charbonneau H, Jaber S, Thoret S, Bosson JL, Piriou V. Non-cardiac surgery in patients with coronary stents: the RECO study. Heart. 2011 Oct;97(19):1566-72. doi: 10.1136/hrt.2011.224519. Epub 2011 Jul 26.
citation: Rossini R, Musumeci G, Capodanno D, Lettieri C, Limbruno U, Tarantini G, Russo N, Calabria P, Romano M, Inashvili A, Sirbu V, Guagliumi G, Valsecchi O, Senni M, Gavazzi A, Angiolillo DJ. Perioperative management of oral antiplatelet therapy and clinical outcomes in coronary stent patients undergoing surgery. Results of a multicentre registry. Thromb Haemost. 2015 Feb;113(2):272-82. doi: 10.1160/TH14-05-0436. Epub 2014 Oct 2.