Clinical trial NCT03445273: Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery
Official title: Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Disease
Lead sponsor: Italian Society of Invasive Cardiology
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with prior percutaneous coronary intervention (PCI) with stent implantation undergoing urgent or elective surgical/endoscopic procedures

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).

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.

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.

Primary outcomes:
measure: Antiplatelet therapy discontinuation in patients with coronary stenting undergoing surgery
timeFrame: 3 months
measure: Antiplatelet therapy discontinuation in patients with coronary stenting undergoing surgery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cuneo
country: Italy
facility: A.O. Santa Croce e Carle di Cuneo
state: CN
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: MI
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: MI
city: Rivoli
country: Italy
facility: Ospedale degli Infermi
state: TO
city: Cosenza
country: Italy
facility: A.O. di Cosenza
city: Roma
country: Italy
facility: Università Campus Bio-Medico di Roma
Study officials:
affiliation: A.O. Santa Croce e Carle di Cuneo, 26 - 12100 - Cuneo (CN)
name: Giuseppe Musumeci, MD
role: PRINCIPAL_INVESTIGATOR
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