PERcutaneouS Coronary intErventions in Patients Treated With Oral Anticoagulant Therapy

NCT03392948 | Unknown DMC

• 1 other identifier: 25/10/2017
• Study Type: observational
• Target: 1,080
• Locations: 1 country
• Sites: 10

Brief Summary

Approximately 5 to 8% of patients undergoing percutaneous coronary interventions requires chronic anticoagulant therapy due to atrial fibrillation or other clinical entities. There are many possible different combinations of the antithrombotic therapy after stent implantation in these patients. Aim of this observational study is to evaluate the real world antithrombotic treatment in patients requiring anticoagulant therapy undergoing stent implantation and to compare the clinical outcome of patients treated with new oral anticoagulant drugs compared to warfarin. The study is prospective, performed in different Italian hospitals and aimed to enroll 1080 patients with a 1 year follow up

Conditions

Acute Myocardial Infarction; Unstable Angina; Chronic Stable Angina

Keywords

atrial fibrillation; prosthetic valves; pulmonary embolism; venous thrombosis; percutaneous coronary interventions; chronic anticoagulant treatment

Outcome Measures

Primary Outcomes (1)

• Net Adverse Clinical Event

  major bleeding, myocardial infarction, death, stroke, myocardial revascularization

  1 year

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 chronic disease requiring oral anticoagulant therapy (atrial fibrillation, prosthetic valves, previous pulmonary embolism, venous thrombosis) undergoing either elective, urgent or emergency percutaneous coronary interventions with stent implantation for acute or chronic coronary disease.

You may qualify if:

• All patients undergoing percutaneous coronary interventions with stent and an indication for chronic anticoagulant therapy.

You may not qualify if:

• Patients of age \< 18 years old
• Lack of written informed consent to participate in the study

Sponsors & Collaborators

• Italian Society of Invasive Cardiology: lead

Study Sites (10)

Ospedale Maggiore Carlo Alberto Pizzardi

Bologna, BO, 40133, Italy

Location

Azienda Ospedaliero - Universitaria "Mater Domini"

Catanzaro, CZ, 88100, Italy

Location

Ospedale della Misericordia

Grosseto, GR, 58100, Italy

Location

A.O.U. Policlinico "G.Martino" - Messina

Messina, ME, 98125, Italy

Location

Ospedale Civile SS Annunziata

Sassari, SS, 07100, Italy

Location

Ospedale SS Filippo e Nicola

Avezzano, 67051, Italy

Location

Ospedale "Vito Fazzi"

Lecce, 73100, Italy

Location

Ospedale "Infermi" di Rimini

Rimini, 47923, Italy

Location

Ospedale S. Eugenio

Roma, 00144, Italy

Location

Ospedale Sandro Pertini

Roma, 00157, Italy

Location

Related Publications (18)

• Rubboli A, Colletta M, Herzfeld J, Sangiorgio P, Di Pasquale G. Periprocedural and medium-term antithrombotic strategies in patients with an indication for long-term anticoagulation undergoing coronary angiography and intervention. Coron Artery Dis. 2007 May;18(3):193-9. doi: 10.1097/MCA.0b013e328012a964.

  PMID: 17429293 BACKGROUND

• Wang TY, Robinson LA, Ou FS, Roe MT, Ohman EM, Gibler WB, Smith SC Jr, Peterson ED, Becker RC. Discharge antithrombotic strategies among patients with acute coronary syndrome previously on warfarin anticoagulation: physician practice in the CRUSADE registry. Am Heart J. 2008 Feb;155(2):361-8. doi: 10.1016/j.ahj.2007.09.003. Epub 2007 Oct 25.

  PMID: 18215609 BACKGROUND

• Leon MB, Baim DS, Popma JJ, Gordon PC, Cutlip DE, Ho KK, Giambartolomei A, Diver DJ, Lasorda DM, Williams DO, Pocock SJ, Kuntz RE. A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent Anticoagulation Restenosis Study Investigators. N Engl J Med. 1998 Dec 3;339(23):1665-71. doi: 10.1056/NEJM199812033392303.

  PMID: 9834303 BACKGROUND

• ACTIVE Writing Group of the ACTIVE Investigators; Connolly S, Pogue J, Hart R, Pfeffer M, Hohnloser S, Chrolavicius S, Pfeffer M, Hohnloser S, Yusuf S. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial. Lancet. 2006 Jun 10;367(9526):1903-12. doi: 10.1016/S0140-6736(06)68845-4.

  PMID: 16765759 BACKGROUND

• Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.

  PMID: 27567408 BACKGROUND

• Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep 17;361(12):1139-51. doi: 10.1056/NEJMoa0905561. Epub 2009 Aug 30.

  PMID: 19717844 BACKGROUND

• Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.

  PMID: 21830957 BACKGROUND

• Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011 Sep 15;365(11):981-92. doi: 10.1056/NEJMoa1107039. Epub 2011 Aug 27.

  PMID: 21870978 BACKGROUND

• Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.

  PMID: 24251359 BACKGROUND

• Oldgren J, Wallentin L, Alexander JH, James S, Jonelid B, Steg G, Sundstrom J. New oral anticoagulants in addition to single or dual antiplatelet therapy after an acute coronary syndrome: a systematic review and meta-analysis. Eur Heart J. 2013 Jun;34(22):1670-80. doi: 10.1093/eurheartj/eht049. Epub 2013 Mar 6.

  PMID: 23470494 BACKGROUND

• Gibson CM, Mehran R, Bode C, Halperin J, Verheugt FW, Wildgoose P, Birmingham M, Ianus J, Burton P, van Eickels M, Korjian S, Daaboul Y, Lip GY, Cohen M, Husted S, Peterson ED, Fox KA. Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI. N Engl J Med. 2016 Dec 22;375(25):2423-2434. doi: 10.1056/NEJMoa1611594. Epub 2016 Nov 14.

  PMID: 27959713 BACKGROUND

• Rubboli A, Saia F, Sciahbasi A, Bacchi-Reggiani ML, Steffanon L, Briguori C, Calabro P, Palmieri C, Rizzi A, Imperadore F, Sangiorgi GM, Valgimigli M, Carosio G, Steffenino G, Galvani M, Di Pasquale G, La Vecchia L, Maggioni AP, Bolognese L; WARfarin and Coronary STENTing (WAR-STENT) Study Group. Outcome of patients on oral anticoagulation undergoing coronary artery stenting: data from discharge to 12 months in the Warfarin and Coronary Stenting (WAR-STENT) Registry. J Invasive Cardiol. 2014 Nov;26(11):563-9.

  PMID: 25363997 BACKGROUND

• Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

  PMID: 21670242 BACKGROUND

• Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.

  PMID: 17470709 BACKGROUND

• Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.

  PMID: 15842354 BACKGROUND

• Rigattieri S, Cristiano E, De Rosa S, Calabro P, Talarico GP, Cortese B, Caruso M, Redivo M, Musumeci G, Sciahbasi A. Peri-Procedural Management of Oral Anticoagulant Therapy in Patients Undergoing Percutaneous Coronary Intervention: Insights from the PERSEO Multicenter Registry. Catheter Cardiovasc Interv. 2025 Aug;106(2):1177-1186. doi: 10.1002/ccd.31657. Epub 2025 Jun 4.

  PMID: 40468540 DERIVED

• Sciahbasi A, De Rosa S, Gargiulo G, Giacoppo D, Calabro P, Talarico GP, Zilio F, Talanas G, Tebaldi M, Ando G, Rigattieri S, Misuraca L, Cortese B, Musuraca G, Lucci V, Guiducci V, Renda G, Zezza L, Versaci F, Giannico MB, Caruso M, Fischetti D, Colletta M, Santarelli A, Larosa C, Iannone A, Esposito G, Tarantini G, Musumeci G, Rubboli A. Management of Patients Treated With Oral Anticoagulant Therapy Undergoing Percutaneous Coronary Intervention With Stent Implantation: The PERSEO Registry. J Cardiovasc Pharmacol. 2024 Oct 1;84(4):457-467. doi: 10.1097/FJC.0000000000001607.

  PMID: 39028879 DERIVED

• Sciahbasi A, Gargiulo G, Talarico GP, Cesaro A, Zilio F, De Rosa S, Talanas G, Tebaldi M, Ando G, Rigattieri S, Misuraca L, Cortese B, Imperadore F, Lucci V, Guiducci V, Renda G, Zezza L, Versaci F, Giannico MB, Caruso M, Spaccarotella C, Calabro P, Esposito G, Tarantini G, Musumeci G, Rubboli A. Design of the PERSEO Registry on the management of patients treated with oral anticoagulants and coronary stent. J Cardiovasc Med (Hagerstown). 2022 Nov 1;23(11):738-743. doi: 10.2459/JCM.0000000000001372. Epub 2022 Sep 7.

  PMID: 36166340 DERIVED

MeSH Terms

Conditions

Angina, Unstable; Angina, Stable; Atrial Fibrillation; Pulmonary Embolism; Venous Thrombosis

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Thrombosis

Study Officials

• Alessandro Sciahbasi, MD

  Ospedale Sandro Pertini, ASL RM2, Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 13 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 8, 2018
• Study Start: February 9, 2018
• Primary Completion: February 28, 2022
• Study Completion: February 1, 2023
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

IT (10)