Clincosm LogoSign in Get a demo

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

Sponsor
Ospedale Santa Croce-Carle Cuneo (Other)
Overall Status
Unknown status
CT.gov ID
NCT03862651
Collaborator
(none)
140
Enrollment
2
Arms
19.1
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: Cangrelor
Cangrelor is an intravenous analog of adenosine triphospate with a potent, selective and specific affinity for P2Y12 receptors.
Other Names:
  • KENGREXAL® (cangrelor)

    		•
    No Intervention: placebo

    patients will receive only standard of care, in which the P2Y12 inhibitor is discontinued after the need for surgery has been determined and a placebo infusion is administered

    Outcome Measures

    Primary Outcome Measures

    1. LEVEL OF RESIDUAL PLATELET REACTIVITY [1-2 hours]

      Accriva VerifyNow P2Y12 assay

    Secondary Outcome Measures

    1. ischemic and hemorrhagic endpoints [30 days]

      Bleeding Academic Research Consortium (BARC) grade > 3

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ospedale Santa Croce-Carle Cuneo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    ROBERTA ROSSINI, Principal Investigator, Ospedale Santa Croce-Carle Cuneo
    ClinicalTrials.gov Identifier:
    NCT03862651
    Other Study ID Numbers:
    • MB11-2018
    First Posted:
    Mar 5, 2019
    Last Update Posted:
    Mar 5, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ROBERTA ROSSINI, Principal Investigator, Ospedale Santa Croce-Carle Cuneo
    aNtiplatElet Therapy
    cangrelor
    randomized
    DAPT
    Additional relevant MeSH terms:
    Cangrelor

    Study Results

    No Results Posted as of Mar 5, 2019