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

Practice Patterns of Antithrombotic Therapy in REAL-world Patients Undergoing PCI in Spain: Parenteral Antiplatelet Agents

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Coronary Syndrome; Ischemic Heart Disease
• Intervention / Treatment: Other: Parenteral antiplatelet agents

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 Type: Observational
• Enrollment (Actual): 717

Contacts and Locations

Study Locations

• Spain
  • Barakaldo, Spain, 48903
    • Hospital Universitario de Cruces
  • Galdakao, Spain, 48960
    • Hospital de Galdakao
  • Gijón, Spain, 33394
    • Hospital Universitario de Cabueñes
  • León, Spain, 24080
    • H.de Leon
  • Madrid, Spain, 28047
    • Hospital Central de la Defensa Gomez Ulla
  • Pamplona, Spain, 31008
    • Hospital Universitario de Navarra
  • Salamanca, Spain, 37007
    • Hospital Clínico Universitario de Salamanca
  • Santander, Spain, 39008
    • Hospital Universitario Marqués de Valdecilla
  • Santiago de Compostela, Spain, 15706
    • Hospital Clinico Universitario Santiago de Compostela
  • Tarragona, Spain, 43005
    • Hospital Universitari Joan XXIII
  • Zaragoza, Spain, 50009
    • Hospital Universitario Lozano Blesa
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a PCI and use of a parenteral antiplatelet agent (GPIs or cangrelor)during the invasive procedure (PCI)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing PCI	Other: Parenteral antiplatelet agents; Patients undergoing PCI and receiving parenteral antiplatelet agents, cangrelor or glycoprotein IIb/IIIa inhibitors (GPIs), during the procedure as per clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	All-cause of death will be evaluated at 48 hours from index procedure	48 hours
Myocardial infarction	Recurrent myocardial infarction will be evaluated at 48 hours from index procedure	48 hours
Stroke	Stroke will be evaluated at 48 hours from index procedure	48 hours
Target Vessel Revascularization	Target Vessel will be evaluated at 48 hours from index procedure	48 hours
Definite or probable stent thrombosis	Definite or probable stent thrombosis will be evaluated at 48 hours from index procedure	48 hours
BARC bleeding	BARC bleeding (type 2,3 and 5) will be evaluated at 48 hours from index procedure	48 hours
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 30 days from index procedure	30 days
Death	All-cause of death will be evaluated at 30 days from index procedure	30 days
Myocardial infarction	Recurrent myocardial infarction will be evaluated at 30 days from index procedure	30 days
Stroke	Stroke will be evaluated at 30 days from index procedure	30 days
Target Vessel Revascularization	Target Vessel Revascularization will be evaluated at 30 days from index procedure	30 days
Definite or probable stent thrombosis	Definite or probable stent thrombosis will be evaluated at 30 days from index procedure	30 days
BARC bleeding	BARC bleeding will be evaluated at 30 days from index procedure	30 days
Cardiac death	Cardiac death will be evaluated at 48 hours from index procedure	48 hours
Cardiac death	Cardiac death will be evaluated at 30 days from index procedure	30 days
Transition to oral P2Y12 inhibitors	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	24 hours

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• Capodanno D, Ferreiro JL, Angiolillo DJ. Antiplatelet therapy: new pharmacological agents and changing paradigms. J Thromb Haemost. 2013 Jun;11 Suppl 1:316-29. doi: 10.1111/jth.12219.
• Bhatt DL, Stone GW, Mahaffey KW, Gibson CM, Steg PG, Hamm CW, Price MJ, Leonardi S, Gallup D, Bramucci E, Radke PW, Widimsky P, Tousek F, Tauth J, Spriggs D, McLaurin BT, Angiolillo DJ, Genereux P, Liu T, Prats J, Todd M, Skerjanec S, White HD, Harrington RA; CHAMPION PHOENIX Investigators. Effect of platelet inhibition with cangrelor during PCI on ischemic events. N Engl J Med. 2013 Apr 4;368(14):1303-13. doi: 10.1056/NEJMoa1300815. Epub 2013 Mar 10.
• Steg PG, Bhatt DL, Hamm CW, Stone GW, Gibson CM, Mahaffey KW, Leonardi S, Liu T, Skerjanec S, Day JR, Iwaoka RS, Stuckey TD, Gogia HS, Gruberg L, French WJ, White HD, Harrington RA; CHAMPION Investigators. Effect of cangrelor on periprocedural outcomes in percutaneous coronary interventions: a pooled analysis of patient-level data. Lancet. 2013 Dec 14;382(9909):1981-92. doi: 10.1016/S0140-6736(13)61615-3. Epub 2013 Sep 3.
• Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.
• Collet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 31, 2021
• First Submitted That Met QC Criteria: December 31, 2021
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Cangrelor; Antiplatelet Drugs; Glycoprotein IIb/IIIa inhibitors
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Acute Coronary Syndrome; Platelet Aggregation Inhibitors
• Other Study ID Numbers: EPIC27-PATREAL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No