Parenteral Antiplatelet Agents in Real-world Spanish PCI Patients (PATREAL)

Fundación EPIC

Status: Enrolling

Conditions: Ischemic Heart Disease; Acute Coronary Syndrome

Treatments: Other: Parenteral antiplatelet agents

Study type: Observational

Funder types: Other

Identifiers

NCT05193019

EPIC27-PATREAL

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Patients undergoing PCI

Treatment:

Other: Parenteral antiplatelet agents