Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery

Coronary Disease Clinical Trial

— MONET  

Official title:

Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03445273
• Other study ID #: 11/01/2018
• Status: Not yet recruiting
• Start date: November 21, 2018
• Est. completion date: November 20, 2019

Study information

• Verified date: July 2018
• Source: Italian Society of Invasive Cardiology
• Contact: Roberta Rossini, MD, PhD
• Phone: 347 2548176
• Email: roberta.rossini2[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1800
• Est. completion date: November 20, 2019
• Est. primary completion date: February 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Locations

Country	Name	City	State
Italy	A.O. di Cosenza	Cosenza
Italy	A.O. Santa Croce e Carle di Cuneo	Cuneo	CN
Italy	Ospedale degli Infermi	Rivoli	TO
Italy	Università Campus Bio-Medico di Roma	Roma
Italy	Istituto Clinico Humanitas	Rozzano	MI
Italy	Istituto Clinico Humanitas	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Italian Society of Invasive Cardiology

Country where clinical trial is conducted

Italy, 

References & Publications (44)

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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