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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03445273
Other study ID # 11/01/2018
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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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Eagle KA, Guyton RA, Davidoff R, Edwards FH, Ewy GA, Gardner TJ, Hart JC, Herrmann HC, Hillis LD, Hutter AM Jr, Lytle BW, Marlow RA, Nugent WC, Orszulak TA, Antman EM, Smith SC Jr, Alpert JS, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Gregoratos G, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK, Ornato JP; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American Society for Thoracic Surgery and the Society of Thoracic Surgeons. ACC/AHA 2004 guideline update for coronary artery bypass graft surgery: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery). Circulation. 2004 Aug 31;110(9):1168-76. Erratum in: Circulation. 2005 Apr 19;111(15):2014. — View Citation

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Fleisher LA, Beckman JA, Brown KA, Calkins H, Chaikof EL, Fleischmann KE, Freeman WK, Froehlich JB, Kasper EK, Kersten JR, Riegel B, Robb JF, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Buller CE, Creager MA, Ettinger SM, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B, Tarkington LG, Yancy CW; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery); American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Rhythm Society; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society for Vascular Surgery. ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery) developed in collaboration with the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery. J Am Coll Cardiol. 2007 Oct 23;50(17):e159-241. Erratum in: J Am Coll Cardiol. 2007 Oct 23;50(17):e242. J Am Coll Cardiol. 2008 Aug 26;52(9):793-4. Chaikof, Elliott [corrected to Chaikof, Elliott L]. — View Citation

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Gurbel PA, DiChiara J, Tantry US. Antiplatelet therapy after implantation of drug-eluting stents: duration, resistance, alternatives, and management of surgical patients. Am J Cardiol. 2007 Oct 22;100(8B):18M-25M. Review. — View Citation

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McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23-29;364(9444):1519-21. — View Citation

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* Note: There are 44 references in allClick 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
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