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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
Sponsor:
Information provided by (Responsible Party):
Italian Society of Invasive Cardiology

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


Condition or disease
Acute Myocardial Infarction Unstable Angina Chronic Stable Angina

Detailed Description:

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:

  1. To describe the contemporary antithrombotic management during and post PCI-S in patients treated with oral anticoagulant therapy
  2. 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


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1080 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners




Primary Outcome Measures :
  1. Net Adverse Clinical Event [ Time Frame: 1 year ]
    major bleeding, myocardial infarction, death, stroke, myocardial revascularization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
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Contact: Alessandro Sciahbasi, MD 3472968314 ext +39 alessandro.sciahbasi@fastwebnet.it
Contact: Andrea Rubboli, MD 335477354 ext +39 andrearubboli@libero.it

Locations
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Italy
Ospedale Maggiore Carlo Alberto Pizzardi Not yet recruiting
Bologna, BO, Italy, 40133
Contact: Andrea AR Rubboli, MD    0516478976 ext +39    andrearubboli@libero.it   
Azienda Ospedaliero - Universitaria "Mater Domini" Recruiting
Catanzaro, CZ, Italy, 88100
Contact: Ciro CI Indolfi, MD    09613647151 ext +39    indolfi@unicz.it   
Contact: Salvatore SD De Rosa, MD, PhD    3398004776 ext +39    saderosa@unicz.it   
Ospedale della Misericordia Not yet recruiting
Grosseto, GR, Italy, 58100
Contact: Leonardo LM Misuraca, MD    0564486158 ext +39    leonardo.misuraca@uslsudest.toscana.it   
A.O.U. Policlinico "G.Martino" - Messina Not yet recruiting
Messina, ME, Italy, 98125
Contact: Giuseppe GA Andò, MD    0902939471 ext +39    giuseppeando1975@gmail.com   
Ospedale Civile SS Annunziata Recruiting
Sassari, SS, Italy, 07100
Contact: Guido GP Parodi, MD    3880451303 ext +39    parodiguido@gmail.com   
Contact: Giuseppe GT Talanas, MD    3880451303 ext +39    giuseppe.talanas@aousassari.it   
Ospedale SS Filippo e Nicola Recruiting
Avezzano, Italy, 67051
Contact: Valerio VL Lucci, MD    3887266264 ext +39    valeriolucci@libero.it   
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    dionigi.fischetti@gmail.com   
Ospedale "Infermi" di Rimini Recruiting
Rimini, Italy, 47923
Contact: Andrea AS Santarelli, MD    3475713721 ext +39    andrea.santarelli@auslromagna.it   
Principal Investigator: Andrea AS Santarelli, MD         
Ospedale S. Eugenio Recruiting
Roma, Italy, 00144
Contact: Gregory GS Sgueglia, MD    3471718642 ext +39    g.a.sgueglia@gmail.com   
Principal Investigator: Gregory GS Sgueglia, MD         
Ospedale Sandro Pertini Recruiting
Roma, Italy, 00157
Contact: Alessandro AS Sciahbasi, MD    3472968314 ext +39    alessandro.sciahbasi@fastwebnet.it   
Principal Investigator: Alessandro AS Sciahbasi, MD         
Sponsors and Collaborators
Italian Society of Invasive Cardiology
Investigators
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Principal Investigator: Alessandro Sciahbasi, MD Ospedale Sandro Pertini, ASL RM2, Rome
  Study Documents (Full-Text)

Documents provided by Italian Society of Invasive Cardiology:

Additional Information:

Publications:

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Responsible Party: Italian Society of Invasive Cardiology
ClinicalTrials.gov Identifier: NCT03392948     History of Changes
Other Study ID Numbers: 25/10/2017
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make Individual Participant Data available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Italian Society of Invasive Cardiology:
atrial fibrillation
prosthetic valves
pulmonary embolism
venous thrombosis
percutaneous coronary interventions
chronic anticoagulant treatment

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Angina Pectoris
Angina, Stable
Angina, Unstable
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Anticoagulants