Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery

NCT ID: NCT03445273

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-21
• Study Completion Date: 2019-11-20

Brief Summary

The MONET registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure. The effects of the application of the Consensus Document "Stent and Surgery-2" on perioperative antiplatelet therapy will be assessed. The study will also assess ischemic and hemorrhagic events in relation to the application of the Consensus Document and length of any antiplatelet discontinuation and delay in performing surgical procedures.

Detailed Description

The MONET registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure at the participating Centers. Centers will be divided into two groups: Centers that routinely follow the recommendations of the SAS 2 Document and Centers that do not. The relevant clinical, procedural and outcome data (within index admission and at 30 days) will be entered in a specifically designed electronic case record form (eCRF). The primary endpoint will be the rate of discontinuation of P2Y12 inhibitors and/or aspirin (without bridging) in the first 3 months after PCI with low risk characteristics and 6 months after PCI with high risk characteristics or any antiplatelet therapy discontinuation without bridging therapy. The secondary end-point will be the composite of death, myocardial infarction, probable/definite stent thrombosis and bleeding events at 30 days; the type and the length of discontinuation of any antiplatelet therapy in patients undergoing surgery according to time from PCI to surgery; delay in performing surgical procedure; rate of surgical procedures within 12 months from PCI divided into quartiles (0-3, 3-6, 6-9, 9-12 months).

Conditions

Coronary Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Eligible will be male and female patients > 18 years of age.
• Eligible will be patients with previous coronary stenting undergoing any kind of surgical or operative endoscopic procedure at the participating Centers, irrespective of the distance in time between stenting and surgery.
• Both candidates to elective and urgent/emergent surgical procedures will be included in the MONET registry.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Italian Society of Invasive Cardiology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Musumeci, MD

Role: PRINCIPAL_INVESTIGATOR

A.O. Santa Croce e Carle di Cuneo, 26 - 12100 - Cuneo (CN)

Locations

A.O. Santa Croce e Carle di Cuneo

Cuneo, CN, Italy

Istituto Clinico Humanitas

Rozzano, MI, Italy

Istituto Clinico Humanitas

Rozzano, MI, Italy

Ospedale degli Infermi

Rivoli, TO, Italy

A.O. di Cosenza

Cosenza, , Italy

Università Campus Bio-Medico di Roma

Roma, , Italy

Countries

Italy

Central Contacts

Roberta Rossini, MD, PhD

Role: CONTACT

roberta.rossini2@gmail.com

347 2548176 ext. +39

Dominick Angiolillo, MD, PhD

Role: CONTACT

dominick.angiolillo@jax.ufl.edu

904-244-3378 ext. +1

Facility Contacts

Giuseppe GM Musumeci, MD

Role: primary

giuseppe.musumeci@gmail.com

3473673582 ext. +39

Roberta RR Rossini, MD, PhD

Role: backup

roberta.rossini2@gmail.com

3472548176 ext. +39

Corrado CL Lodigiani, MD

Role: primary

corrado.lodigiani@humanitas.it

0282248307 ext. +39

Bernhard BR Reimers, MD

Role: primary

bernhard.reimers@humanitas.it

3385966716 ext. +39

Ferdinando FV Varbella, MD

Role: primary

varbella@gmail.com

3487155989 ext. +39

Roberto RC Caporale, MD

Role: primary

caporale.roberto@gmail.com

3473368179 ext. +39

Elisabetta ER Ricottini, MD, PhD

Role: primary

e.ricottini@unicampus.it

3318675311 ext. +39

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

11/01/2018

Identifier Type: -

Identifier Source: org_study_id