NCT03862651

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

1.6 years

First QC Date

February 22, 2019

Last Update Submit

March 4, 2019

Conditions

Platelet Aggregation Inhibitors

Keywords

aNtiplatElet TherapycangrelorrandomizedDAPT

Outcome Measures

Primary Outcomes (1)

  • LEVEL OF RESIDUAL PLATELET REACTIVITY

    Accriva VerifyNow P2Y12 assay

    1-2 hours

Secondary Outcomes (1)

  • ischemic and hemorrhagic endpoints

    30 days

Study Arms (2)

Cangrelor

EXPERIMENTAL

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

placebo

NO INTERVENTION

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

Interventions

CangrelorDRUG

Cangrelor is an intravenous analog of adenosine triphospate with a potent, selective and specific affinity for P2Y12 receptors.

Also known as: KENGREXAL® (cangrelor)
Cangrelor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provide written informed consent before initiation of any study related procedures.
  • Be ≥ 18 years of age.
  • Have received any dose of a P2Y12 inhibitor (clopidogrel, ticlopidine, prasugrel, or ticagrelor) at any dose within at least 48 hours prior to randomization.
  • Patients undergoing non deferrable cardiac or non cardiac surgery which requires discontinuation of P2Y12 inhibitor due to a significant bleeding risk.

You may not qualify if:

  • Confirmed of suspected pregnancy (if woman of child-bearing potential) or lactating females
  • Active bleeding with evident contraindications to DAPT
  • Patients requiring oral anticoagulant therapy
  • PCI within 1 month
  • Intracranial neoplasm or history of intracranial surgery
  • History of bleeding diathesis
  • Thrombocytopenia (platelet count of less than 100,000/µL)
  • Known International Normalized Ratio (INR) greater than 1.5 at screening.
  • Requirement for dialysis treatment (hemodialysis or peritoneal)
  • Estimated Glomeular filtration rate eGFR \<30 ml/min
  • Administration of abciximab within 24 hours of randomization or administration of eptifibitide or tirofiban within 12 hours of randomization
  • Plans to continue oral anticoagulant or P2Y12 inhibitors or cangrelor in the pre-operative period
  • Refusal to receive blood transfusion
  • Receipt of fibrinolytic therapy in the 12 hours preceding randomization
  • Allergy, hypersensitivity, or contraindication to cangrelor, mannitol, sorbitol, or microcrystalline cellulose
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez 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. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10):e646. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

    PMID: 28122885BACKGROUND

  • Moschovitis A, Cook S, Meier B. Percutaneous coronary interventions in Europe in 2006. EuroIntervention. 2010 Jun;6(2):189-94. doi: 10.4244/EIJV7I6A31.

    PMID: 20562067BACKGROUND

  • Brilakis ES, Banerjee S, Berger PB. Perioperative management of patients with coronary stents. J Am Coll Cardiol. 2007 Jun 5;49(22):2145-50. doi: 10.1016/j.jacc.2007.02.046. Epub 2007 May 23.

    PMID: 17543633BACKGROUND

  • Schouten O, van Domburg RT, Bax JJ, de Jaegere PJ, Dunkelgrun M, Feringa HH, Hoeks SE, Poldermans D. Noncardiac surgery after coronary stenting: early surgery and interruption of antiplatelet therapy are associated with an increase in major adverse cardiac events. J Am Coll Cardiol. 2007 Jan 2;49(1):122-4. doi: 10.1016/j.jacc.2006.10.004. Epub 2006 Dec 18. No abstract available.

    PMID: 17207733BACKGROUND

  • Albaladejo P, Marret E, Samama CM, Collet JP, Abhay K, Loutrel O, Charbonneau H, Jaber S, Thoret S, Bosson JL, Piriou V. Non-cardiac surgery in patients with coronary stents: the RECO study. Heart. 2011 Oct;97(19):1566-72. doi: 10.1136/hrt.2011.224519. Epub 2011 Jul 26.

    PMID: 21791513BACKGROUND

  • Rossini R, Musumeci G, Capodanno D, Lettieri C, Limbruno U, Tarantini G, Russo N, Calabria P, Romano M, Inashvili A, Sirbu V, Guagliumi G, Valsecchi O, Senni M, Gavazzi A, Angiolillo DJ. Perioperative management of oral antiplatelet therapy and clinical outcomes in coronary stent patients undergoing surgery. Results of a multicentre registry. Thromb Haemost. 2015 Feb;113(2):272-82. doi: 10.1160/TH14-05-0436. Epub 2014 Oct 2.

    PMID: 25274620BACKGROUND

MeSH Terms

Interventions

cangrelor

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2019

First Posted

March 5, 2019

Study Start

June 1, 2019

Primary Completion

December 31, 2020

Study Completion

January 1, 2021

Last Updated

March 5, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share