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

November 12, 2018 updated by: Italian Society of Invasive Cardiology
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.

Study Overview

Status

Unknown

Conditions

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).

Study Type

Observational

Enrollment (Anticipated)

1800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Cosenza, Italy
        • A.O. di Cosenza
        • Contact:
        • Principal Investigator:
          • Roberto RC Caporale, MD
      • Roma, Italy, 00128
        • Università Campus Bio-Medico di Roma
        • Contact:
    • CN
    • MI
      • Rozzano, MI, Italy, 20089
    • TO
      • Rivoli, TO, Italy, 10098
        • Ospedale Degli Infermi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with prior percutaneous coronary intervention (PCI) with stent implantation undergoing urgent or elective surgical/endoscopic procedures

Description

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.

Exclusion Criteria:

  • Unwillingness/inability to sign the Informed Consent Form (ICF). Patients with an active bleeding requiring discontinuation of one or both antiplatelet agents will be also excluded. There are no other exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antiplatelet therapy discontinuation in patients with coronary stenting undergoing surgery
Time Frame: 3 months
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
3 months
Antiplatelet therapy discontinuation in patients with coronary stenting undergoing surgery
Time Frame: 6 months
Rate of discontinuation of P2Y12 inhibitors and/or aspirin (without bridging) in the first 6 months after PCI with high risk characteristics or any antiplatelet therapy discontinuation without bridging therapy
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italian Society of Invasive Cardiology

Investigators

  • Principal Investigator: Giuseppe Musumeci, MD, A.O. Santa Croce e Carle di Cuneo, 26 - 12100 - Cuneo (CN)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 21, 2018

Primary Completion (Anticipated)

February 21, 2019

Study Completion (Anticipated)

November 20, 2019

Study Registration Dates

First Submitted

February 16, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 26, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/01/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is not yet known if there will be a plan to make Individual Participant Data available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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