PERcutaneouS Coronary intErventions in Patients Treated With Oral Anticoagulant Therapy (PERSEO)
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|ClinicalTrials.gov Identifier: NCT03392948|
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : November 19, 2018
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
|Condition or disease|
|Acute Myocardial Infarction Unstable Angina Chronic Stable Angina|
Approximately 5 to 8% of patients undergoing percutaneous coronary interventions requires chronic anticoagulant therapy due to atrial fibrillation or other clinical entities. These patients pose particular problems when undergo percutaneous coronary intervention with stent implantation (PCI-S), because of the different antithrombotic and oral anticoagulant (OAC) strategies required after the procedure when dual antiplatelet therapy is recommended. Consequently, this scenario requires careful consideration balancing bleeding, stroke and acute coronary syndrome risks.
New oral anticoagulants (NOAC) have been compared to warfarin for stroke prevention in the setting of atrial fibrillation and all these drugs showed a similar or improved efficacy over warfarin in term of ischemic events as well as bleeding complications reduction. In particular, an important safety issue is the reduction of intracranial bleeding compared to warfarin. Currently, four different NOAC have been approved for the treatment of patients with atrial fibrillation: apixaban, edoxaban, rivaroxaban and dabigatran. The first three drugs are anti Xa inhibitors whereas the last one is a direct thrombin inhibitor.
Data regarding the combination of NOAC and antiplatelet therapy after PCI-S in patients requiring chronic anticoagulant therapy are currently scarce.
The aim of our study is to perform a prospective, multicenter, observational, controlled study on patients requiring chronic anticoagulant treatment with either vitamin K antagonists or NOAC undergoing PCI-S for concomitant coronary disease.
The primary objectives of the study are:
- To describe the contemporary antithrombotic management during and post PCI-S in patients treated with oral anticoagulant therapy
- To evaluate, in this context, the efficacy and safety of the different NAOC compared to warfarin regimens.
According to the observational design of the study, anticoagulant therapy (vitamin antagonists or new oral anticoagulant drugs), other pharmacological therapy as well as procedural device utilized, before, during the procedure and at follow-up will be left to the physician decision.
The events will be adjudicated by a clinical event committee (CEC) comprised of qualified physicians. The CEC is responsible for adjudicating all potential endpoint events, including death, bleeding, myocardial infarction, stent thrombosis, stroke, and coronary revascularization
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1080 participants|
|Target Follow-Up Duration:||13 Months|
|Official Title:||PERcutaneouS Coronary intErventions in Patients Treated With Oral Anticoagulant Therapy|
|Actual Study Start Date :||February 9, 2018|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2020|
- Net Adverse Clinical Event [ Time Frame: 1 year ]major bleeding, myocardial infarction, death, stroke, myocardial revascularization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392948
|Contact: Alessandro Sciahbasi, MD||3472968314 ext +email@example.com|
|Contact: Andrea Rubboli, MD||335477354 ext +firstname.lastname@example.org|
|Ospedale Maggiore Carlo Alberto Pizzardi||Not yet recruiting|
|Bologna, BO, Italy, 40133|
|Contact: Andrea AR Rubboli, MD 0516478976 ext +39 email@example.com|
|Azienda Ospedaliero - Universitaria "Mater Domini"||Recruiting|
|Catanzaro, CZ, Italy, 88100|
|Contact: Ciro CI Indolfi, MD 09613647151 ext +39 firstname.lastname@example.org|
|Contact: Salvatore SD De Rosa, MD, PhD 3398004776 ext +39 email@example.com|
|Ospedale della Misericordia||Not yet recruiting|
|Grosseto, GR, Italy, 58100|
|Contact: Leonardo LM Misuraca, MD 0564486158 ext +39 firstname.lastname@example.org|
|A.O.U. Policlinico "G.Martino" - Messina||Not yet recruiting|
|Messina, ME, Italy, 98125|
|Contact: Giuseppe GA Andò, MD 0902939471 ext +39 email@example.com|
|Ospedale Civile SS Annunziata||Recruiting|
|Sassari, SS, Italy, 07100|
|Contact: Guido GP Parodi, MD 3880451303 ext +39 firstname.lastname@example.org|
|Contact: Giuseppe GT Talanas, MD 3880451303 ext +39 email@example.com|
|Ospedale SS Filippo e Nicola||Recruiting|
|Avezzano, Italy, 67051|
|Contact: Valerio VL Lucci, MD 3887266264 ext +39 firstname.lastname@example.org|
|Principal Investigator: Valerio VL Lucci, MD|
|Sub-Investigator: Valentina VB Basso, MD|
|Ospedale "Vito Fazzi"||Recruiting|
|Lecce, Italy, 73100|
|Contact: Dionigi DF Fischetti, MD 3471928024 ext +39 email@example.com|
|Ospedale "Infermi" di Rimini||Recruiting|
|Rimini, Italy, 47923|
|Contact: Andrea AS Santarelli, MD 3475713721 ext +39 firstname.lastname@example.org|
|Principal Investigator: Andrea AS Santarelli, MD|
|Ospedale S. Eugenio||Recruiting|
|Roma, Italy, 00144|
|Contact: Gregory GS Sgueglia, MD 3471718642 ext +39 email@example.com|
|Principal Investigator: Gregory GS Sgueglia, MD|
|Ospedale Sandro Pertini||Recruiting|
|Roma, Italy, 00157|
|Contact: Alessandro AS Sciahbasi, MD 3472968314 ext +39 firstname.lastname@example.org|
|Principal Investigator: Alessandro AS Sciahbasi, MD|
|Principal Investigator:||Alessandro Sciahbasi, MD||Ospedale Sandro Pertini, ASL RM2, Rome|