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

March 4, 2019 updated by: ROBERTA ROSSINI, Ospedale Santa Croce-Carle Cuneo

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LEVEL OF RESIDUAL PLATELET REACTIVITY
Time Frame: 1-2 hours
Accriva VerifyNow P2Y12 assay
1-2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ischemic and hemorrhagic endpoints
Time Frame: 30 days
Bleeding Academic Research Consortium (BARC) grade > 3
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Santa Croce-Carle Cuneo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

February 22, 2019

First Submitted That Met QC Criteria

March 4, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB11-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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