Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery (MONET BRIDGE)

Phase 2

• Conditions: Platelet Aggregation Inhibitors
• Interventions: Drug: Cangrelor

• Registration Number: NCT03862651
• Lead Sponsor: Ospedale Santa Croce-Carle Cuneo

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.

Study Timeline

• Study First Submitted: 2019-02-22
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-04
• Last Update Submitted: 2019-03-04
• Study First Posted: 2019-03-05
• Last Update Posted: 2019-03-05
• Study Start: 2019-06-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cangrelor	Cangrelor	Cangrelor, 0.75 μg/Kg/min, a cangrelor infusion will be started in addition to SOC when the P2Y12 inhibitor has been discontinued after the need for surgery has been determined. The infusions (cangrelor or matching placebo) will continue throughout the pre-operative period

Primary Outcome Measures

Name	Time	Method
LEVEL OF RESIDUAL PLATELET REACTIVITY	1-2 hours	Accriva VerifyNow P2Y12 assay

Secondary Outcome Measures

Name	Time	Method
ischemic and hemorrhagic endpoints	30 days	Bleeding Academic Research Consortium (BARC) grade \> 3