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

• Status: Unknown status
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ospedale Santa Croce-Carle Cuneo
• Treatments: Cangrelor

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