Parenteral Antiplatelet Agents in Real-world Spanish PCI Patients

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.

Full Title of Study: “Practice Patterns of Antithrombotic Therapy in REAL-world Patients Undergoing PCI in Spain: Parenteral Antiplatelet Agents”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 1, 2023

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Patients undergoing PCI

Clinical Trial Outcome Measures

Primary Measures

  • Rate of Net Adverse Clinical Events (NACE)
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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 <100×106/ml at the time of the index procedure. – Any active neoplasm.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundación EPIC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • José Luis Ferreiro Gutiérrez, MD, PhD, +34 93 2607539, jlferreiro@bellvitgehospital.cat

References

Collet JP, Thiele H, Barbato E, Barthélémy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Jüni 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. Erratum in: Eur Heart J. 2021 May 14;42(19):1908. Erratum in: Eur Heart J. 2021 May 14;42(19):1925. Eur Heart J. 2021 May 13;:.

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. Review.

Bhatt DL, Stone GW, Mahaffey KW, Gibson CM, Steg PG, Hamm CW, Price MJ, Leonardi S, Gallup D, Bramucci E, Radke PW, Widimský P, Tousek F, Tauth J, Spriggs D, McLaurin BT, Angiolillo DJ, Généreux 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, Jüni 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. Erratum in: Eur Heart J. 2019 Oct 1;40(37):3096.

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