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Platelet Aggregation InhibitorsPhase 2NCT03862651

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

A Phase 2 study testing Cangrelor in people with Platelet Aggregation Inhibitors, run by Ospedale Santa Croce-Carle Cuneo.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Platelet Aggregation Inhibitors
What is being tested?
Cangrelor
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
No sites listed yet
Study dates
1 Jun 2019to 1 Jan 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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
  • High likelihood of being unavailable for follow-up
  • Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization
  • Any disease or condition which, in the judgment of the investigator, would place the patient at undue risk by being enrolled in the trial

About this study

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)

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.

Read the 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.

Being tested
Cangrelor
Keywords
aNtiplatElet Therapy, cangrelor, randomized, DAPT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CangrelorDrug

    Also called KENGREXAL® (cangrelor)

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

Study groups in NCT03862651
Study groupRoleWhat they receive
CangrelorExperimentalCangrelor, 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
Receives: Drug: Cangrelor
placeboNo interventionpatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. LEVEL OF RESIDUAL PLATELET REACTIVITY

    Accriva VerifyNow P2Y12 assay

    Measured: 1-2 hours

Secondary outcomes (1)

  1. ischemic and hemorrhagic endpoints

    Bleeding Academic Research Consortium (BARC) grade > 3

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2019
  2. Study start1 Jun 2019 (estimated)
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion1 Jan 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03862651
Sponsor's protocol ID
MB11-2018
Status last verified
Mar 2019
First submitted
22 Feb 2019
Last updated
5 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28122885

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

    PubMed 20562067

  • 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.

    PubMed 17543633

  • 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.

    PubMed 17207733

  • 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.

    PubMed 21791513

  • 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.

    PubMed 25274620

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cangrelor in people with Platelet Aggregation Inhibitors, run by Ospedale Santa Croce-Carle Cuneo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LEVEL OF RESIDUAL PLATELET REACTIVITY (time frame: 1-2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03862651, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.

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