PERcutaneouS Coronary intErventions in Patients Treated With Oral Anticoagulant Therapy

NCT ID: NCT03392948

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1080 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-09
• Study Completion Date: 2023-02-28

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

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

Conditions

Acute Myocardial Infarction; Unstable Angina; Chronic Stable Angina

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Italian Society of Invasive Cardiology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandro Sciahbasi, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Sandro Pertini, ASL RM2, Rome

Locations

Ospedale Maggiore Carlo Alberto Pizzardi

Bologna, BO, Italy

Azienda Ospedaliero - Universitaria "Mater Domini"

Catanzaro, CZ, Italy

Ospedale della Misericordia

Grosseto, GR, Italy

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

Messina, ME, Italy

Ospedale Civile SS Annunziata

Sassari, SS, Italy

Ospedale SS Filippo e Nicola

Avezzano, , Italy

Ospedale "Vito Fazzi"

Lecce, , Italy

Ospedale "Infermi" di Rimini

Rimini, , Italy

Ospedale S. Eugenio

Roma, , Italy

Ospedale Sandro Pertini

Roma, , Italy

Countries

Italy

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

25/10/2017

Identifier Type: -

Identifier Source: org_study_id