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

  NCT03862651

  Unknown statusInterventionalPhase 2Updated Mar 5, 2019
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ClinicalTrials.gov ID

NCT03445273

Lead Sponsor

Italian Society of Invasive CardiologyOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

1,800Estimated

Last Update Posted

Nov 14, 2018Actual

Start Date

Nov 21, 2018Estimated

Primary Completion Date

Feb 21, 2019Estimated

Completion Date

Nov 20, 2019Estimated

Official Title

Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery

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).

• Coronary Disease

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Observational Model

Other

Time Perspective

Prospective

Lead Sponsor

Italian Society of Invasive CardiologyOTHER

corrado.lodigiani@humanitas.it0282248307 ext. +39

bernhard.reimers@humanitas.it3385966716 ext. +39

varbella@gmail.com3487155989 ext. +39

caporale.roberto@gmail.com3473368179 ext. +39

e.ricottini@unicampus.it3318675311 ext. +39