Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery

• Conditions: Coronary Disease

• Registration Number: NCT03445273
• Lead Sponsor: Italian Society of Invasive Cardiology

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).

Study Timeline

• Study First Submitted: 2018-02-16
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-26
• Status Verified: 2018-07
• Last Update Submitted: 2018-11-12
• Last Update Posted: 2018-11-14
• Study Start: 2018-11-21
• Primary Completion: 2019-02-21
• Study Completion: 2019-11-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antiplatelet therapy discontinuation in patients with coronary stenting undergoing surgery	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

Trial Locations

Locations (5)

A.O. Santa Croce e Carle di Cuneo; 🇮🇹 Cuneo, CN, 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