Parenteral Antiplatelet Agents in Real-world Spanish PCI Patients

N/AActive Not RecruitingNCT05193019

Fundación EPIC717 enrolled

Overview

This registry will provide exploratory and descriptive information regarding contemporary practice patterns of parenteral antiplatelet therapy in the PCI (Percutaneous Coronary Intervention) setting and will investigate as well the short-term effectiveness and safety of the currently available parenteral antiplatelet agents in a cohort of "real-world" patients undergoing PCI in Spain.

The present study is an observational, multicenter, nationwide, prospective investigation in patients undergoing PCI due to any coronary syndrome (acute or chronic) and receiving parenteral antiplatelet agents, GPIs or cangrelor, as per clinical practice during the procedure. This investigation will provide exploratory and descriptive information regarding contemporary practice patterns of parenteral antiplatelet therapy in the PCI setting and will evaluate the short-term effectiveness and safety of the currently available parenteral antiplatelet agents in a cohort of patients undergoing PCI in Spain. Approximately 15 high-volume PCI-capable Spanish centers will participate in the present investigation with the intention to enroll circa 1.000 patients. The study is purely observational and no intervention will be performed in the included subjects because due to their participation in this investigation. Patients fulfilling inclusion and exclusion criteria will be included after providing written informed consent to participate in the current investigation. Patient characteristics, procedural details and pharmacological therapies will be collected after inclusion and clinical events will be registered at two time points: 48 hours and 30 days.

Study Type

OBSERVATIONAL

Enrollment

717

Conditions

Ischemic Heart Disease Acute Coronary Syndrome

Interventions

Parenteral antiplatelet agentsOTHER

Patients undergoing PCI and receiving parenteral antiplatelet agents, cangrelor or glycoprotein IIb/IIIa inhibitors (GPIs), during the procedure as per clinical practice

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥18 years * Undergoing a PCI * Use of a parenteral antiplatelet agent (GPIs or cangrelor)during the invasive procedure (PCI) Exclusion Criteria: * Blood dyscrasia, bleeding diathesis or active bleeding at the time of the index procedure. * Chronic oral anticoagulation. * Recent history of stroke, TIA (Transient Ischemic Attack)or intracranial bleeding (\<3 months prior to inclusion). * Severe anemia (Hb\<9g/dl) or platelet count \<100x106/ml at the time of the index procedure. * Any active neoplasm.

Locations (12)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario de Cruces

Barakaldo, Spain

Hospital de Galdakao

Galdakao, Spain

Outcomes

Primary Outcomes

Rate of Net Adverse Clinical Events (NACE)

NACE defined as a the composite of all-cause death, recurrent myocardial infarction, stroke, target vessel revascularization, definite or probable stent thrombosis and BARC bleeding (type 2,3 and 5) will be evaluated at 48 hours from index procedure

Time frame: 48 hours

Secondary Outcomes

Death

All-cause of death will be evaluated at 48 hours from index procedure

Time frame: 48 hours

Myocardial infarction

Recurrent myocardial infarction will be evaluated at 48 hours from index procedure

Time frame: 48 hours

Stroke

Stroke will be evaluated at 48 hours from index procedure

Time frame: 48 hours

Target Vessel Revascularization

Target Vessel will be evaluated at 48 hours from index procedure

Time frame: 48 hours

Definite or probable stent thrombosis

Definite or probable stent thrombosis will be evaluated at 48 hours from index procedure

Time frame: 48 hours

BARC bleeding

BARC bleeding (type 2,3 and 5) will be evaluated at 48 hours from index procedure

Time frame: 48 hours

Rate of Net Adverse Clinical Events (NACE)

Data from ClinicalTrials.gov

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