Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery

NCT03445273 | Unknown

• 1 other identifier: 11/01/2018
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 6

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.

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (2)

• Antiplatelet therapy discontinuation in patients with coronary stenting undergoing surgery

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Italian Society of Invasive Cardiology: lead

Study Sites (6)

A.O. Santa Croce e Carle di Cuneo

Cuneo, CN, 12100, Italy

Location

Istituto Clinico Humanitas

Rozzano, MI, 20089, Italy

Location

Istituto Clinico Humanitas

Rozzano, MI, 20089, Italy

Location

Ospedale degli Infermi

Rivoli, TO, 10098, Italy

Location

A.O. di Cosenza

Cosenza, Italy

Location

Università Campus Bio-Medico di Roma

Roma, 00128, Italy

Location

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MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Giuseppe Musumeci, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Rossini, MD, PhD

CONTACT

347 2548176; roberta.rossini2@gmail.com

Dominick Angiolillo, MD, PhD

CONTACT

904-244-3378; dominick.angiolillo@jax.ufl.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 26, 2018
• Study Start: November 21, 2018
• Primary Completion: February 21, 2019
• Study Completion: November 20, 2019
• Last Updated: November 14, 2018

Record last verified: 2018-07

Locations

IT (6)