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

Platelet Aggregation Inhibitors Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03862651
• Other study ID #: MB11-2018
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: March 2019
• Source: Ospedale Santa Croce-Carle Cuneo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: January 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Platelet Aggregation Inhibitors

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Santa Croce-Carle Cuneo

References & Publications (6)

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. — View Citation

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. — View Citation

Brilakis ES, Banerjee S, Berger PB. Perioperative management of patients with coronary stents. J Am Coll Cardiol. 2007 Jun 5;49(22):2145-50. Epub 2007 May 23. Review. — View Citation

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

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. — View Citation

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. Epub 2006 Dec 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LEVEL OF RESIDUAL PLATELET REACTIVITY	Accriva VerifyNow P2Y12 assay	1-2 hours
Secondary	ischemic and hemorrhagic endpoints	Bleeding Academic Research Consortium (BARC) grade > 3	30 days