Parenteral Antiplatelet Agents in Real-world Spanish PCI Patients

NCT05193019 | Active Not Recruiting DMC

• 1 other identifier: EPIC27-PATREAL
• Study Type: observational
• Target: 717
• Locations: 1 country
• Sites: 12

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.

Conditions

Ischemic Heart Disease; Acute Coronary Syndrome

Keywords

Percutaneous Coronary Intervention; Antiplatelet Drugs; Cangrelor; Glycoprotein IIb/IIIa inhibitors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Death

  48 hours

• Myocardial infarction

  48 hours

• Stroke

  48 hours

• Target Vessel Revascularization

  48 hours

• Definite or probable stent thrombosis

  48 hours

Study Arms (1)

Patients undergoing PCI

Other: Parenteral antiplatelet agents

Interventions

Parenteral antiplatelet agents OTHER

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

Patients undergoing PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Age ≥18 years
• Undergoing a PCI
• Use of a parenteral antiplatelet agent (GPIs or cangrelor)during the invasive procedure (PCI)

You may not qualify if:

• Blood dyscrasia, bleeding diathesis or active bleeding at the time of the index procedure.
• Chronic oral anticoagulation.
• Severe anemia (Hb\<9g/dl) or platelet count \<100x106/ml at the time of the index procedure.
• Any active neoplasm.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (12)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario de Cruces

Barakaldo, 48903, Spain

Location

Hospital de Galdakao

Galdakao, 48960, Spain

Location

Hospital Universitario de Cabueñes

Gijón, 33394, Spain

Location

H.de Leon

León, 24080, Spain

Location

Hospital Central de La Defensa Gómez Ulla

Madrid, 28047, Spain

Location

Hospital Universitario de Navarra

Pamplona, 31008, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Hospital Universitari Joan Xxiii

Tarragona, 43005, Spain

Location

Hospital Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Related Publications (5)

• 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.

  PMID: 32860058 BACKGROUND

• 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.

  PMID: 23809135 BACKGROUND

• 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.

  PMID: 23473369 BACKGROUND

• 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.

  PMID: 24011551 BACKGROUND

• 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.

  PMID: 30165437 BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: January 14, 2022
• Study Start: March 14, 2022
• Primary Completion: May 1, 2026
• Study Completion: June 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

ES (12)