Clinical trial NCT05193019: Parenteral Antiplatelet Agents in Real-world Spanish PCI Patients
Official title: Practice Patterns of Antithrombotic Therapy in REAL-world Patients Undergoing PCI in Spain: Parenteral Antiplatelet Agents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Heart Disease
Acute Coronary Syndrome
Keywords: Percutaneous Coronary Intervention
Antiplatelet Drugs
Cangrelor
Glycoprotein IIb/IIIa inhibitors
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Net Adverse Clinical Events (NACE)
timeFrame: 48 hours
Secondary outcomes:
measure: Death
timeFrame: 48 hours
measure: Myocardial infarction
timeFrame: 48 hours
measure: Stroke
timeFrame: 48 hours
measure: Target Vessel Revascularization
timeFrame: 48 hours
measure: Definite or probable stent thrombosis
timeFrame: 48 hours
measure: BARC bleeding
timeFrame: 48 hours
measure: Rate of Net Adverse Clinical Events (NACE)
timeFrame: 30 days
measure: Death
timeFrame: 30 days
measure: Myocardial infarction
timeFrame: 30 days
measure: Stroke
timeFrame: 30 days
measure: Target Vessel Revascularization
timeFrame: 30 days
measure: Definite or probable stent thrombosis
timeFrame: 30 days
measure: BARC bleeding
timeFrame: 30 days
measure: Cardiac death
timeFrame: 48 hours
measure: Cardiac death
timeFrame: 30 days
measure: Transition to oral P2Y12 inhibitors
timeFrame: 24 hours
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
city: Galdakao
country: Spain
facility: Hospital de Galdakao
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
city: León
country: Spain
facility: H.de Leon
city: Madrid
country: Spain
facility: Hospital Central de La Defensa Gómez Ulla
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Universitario Santiago de Compostela
city: Tarragona
country: Spain
facility: Hospital Universitari Joan Xxiii
city: Zaragoza
country: Spain
facility: Hospital Universitario Lozano Blesa
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.