Coronary Disease Clinical Trial
— MONETOfficial title:
Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Italian Society of Invasive Cardiology |
Italy,
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* Note: There are 44 references in all — Click here to view all references
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 |
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