Parenteral Antiplatelet Agents in Real-world Spanish PCI Patients

Recruiting

• Conditions: Acute Coronary Syndrome; Ischemic Heart Disease
• Interventions: Other: Parenteral antiplatelet agents

• Registration Number: NCT05193019
• Lead Sponsor: Fundación EPIC

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-31
• Study First Submitted QC: 2021-12-31
• Study First Posted: 2022-01-14
• Study Start: 2022-03-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing PCI	Parenteral antiplatelet agents	-

Primary Outcome Measures

Name	Time	Method
Rate of Net Adverse Clinical Events (NACE)	48 hours	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

Secondary Outcome Measures

Name	Time	Method
Stroke	30 days	Stroke will be evaluated at 30 days from index procedure
Cardiac death	30 days	Cardiac death will be evaluated at 30 days from index procedure
Definite or probable stent thrombosis	30 days	Definite or probable stent thrombosis will be evaluated at 30 days from index procedure
BARC bleeding	30 days	BARC bleeding will be evaluated at 30 days from index procedure
Death	30 days	All-cause of death will be evaluated at 30 days from index procedure
Myocardial infarction	30 days	Recurrent myocardial infarction will be evaluated at 30 days from index procedure
Target Vessel Revascularization	30 days	Target Vessel Revascularization will be evaluated at 30 days from index procedure
Rate of Net Adverse Clinical Events (NACE)	30 days	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 30 days from index procedure
Transition to oral P2Y12 inhibitors	24 hours	Proportion of patients transitioned to each oral P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) after the use of each parenteral antiplatelet agent (GPIs or cangrelor) will be evaluated at 24 hours from index procedure

Trial Locations

Locations (12)

Hospital Clinico Universitario Santiago de Compostela; 🇪🇸 Santiago De Compostela, Spain

Hospital Universitari Joan Xxiii; 🇪🇸 Tarragona, Spain

Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital Universitario de Cruces; 🇪🇸 Barakaldo, Spain

Hospital de Galdakao; 🇪🇸 Galdakao, Spain

H.de Leon; 🇪🇸 León, Spain

Hospital Clinico Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitario de Cabueñes; 🇪🇸 Gijón, Spain

Hospital Universitario de Navarra; 🇪🇸 Pamplona, Spain

Hospital Central de La Defensa Gómez Ulla; 🇪🇸 Madrid, Spain