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Trial record 11 of 27 for:    cangrelor

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

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ClinicalTrials.gov Identifier: NCT03862651
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
ROBERTA ROSSINI, 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.

Condition or disease Intervention/treatment Phase
Platelet Aggregation Inhibitors Drug: Cangrelor 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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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)
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Cangrelor

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 Name: 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



Primary Outcome Measures :
  1. LEVEL OF RESIDUAL PLATELET REACTIVITY [ Time Frame: 1-2 hours ]
    Accriva VerifyNow P2Y12 assay


Secondary Outcome Measures :
  1. ischemic and hemorrhagic endpoints [ Time Frame: 30 days ]
    Bleeding Academic Research Consortium (BARC) grade > 3



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications:
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.

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Responsible Party: ROBERTA ROSSINI, Principal Investigator, Ospedale Santa Croce-Carle Cuneo
ClinicalTrials.gov Identifier: NCT03862651     History of Changes
Other Study ID Numbers: MB11-2018
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ROBERTA ROSSINI, Ospedale Santa Croce-Carle Cuneo:
aNtiplatElet Therapy
cangrelor
randomized
DAPT
Additional relevant MeSH terms:
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Cangrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs