Parenteral Antiplatelet Agents in Real-world Spanish PCI Patients

Acute Coronary Syndrome Clinical Trial

— PATREAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05193019
• Other study ID #: EPIC27-PATREAL
• Status: Recruiting
• Start date: March 14, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2023
• Source: Fundación EPIC
• Contact: José Luis Ferreiro Gutiérrez, MD, PhD
• Phone: +34 93 2607539
• Email: jlferreiro[@]bellvitgehospital.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario de Cruces	Barakaldo
Spain	Hospital de Galdakao	Galdakao
Spain	Hospital Universitario de Cabueñes	Gijón
Spain	Hospital Universitari de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	H.de Leon	León
Spain	Hospital Central de La Defensa Gómez Ulla	Madrid
Spain	Hospital Universitario de Navarra	Pamplona
Spain	Hospital Clinico Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Marques de Valdecilla	Santander
Spain	Hospital Clinico Universitario Santiago de Compostela	Santiago De Compostela
Spain	Hospital Universitari Joan Xxiii	Tarragona
Spain	Hospital Universitario Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. — View 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. Erratum In: Eur Heart J. 2021 May 14;42(19):1908. Eur Heart J. 2021 May 14;42(19):1925. Eur Heart J. 2021 May 13;: — View 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. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Death	All-cause of death will be evaluated at 48 hours from index procedure	48 hours
Secondary	Myocardial infarction	Recurrent myocardial infarction will be evaluated at 48 hours from index procedure	48 hours
Secondary	Stroke	Stroke will be evaluated at 48 hours from index procedure	48 hours
Secondary	Target Vessel Revascularization	Target Vessel will be evaluated at 48 hours from index procedure	48 hours
Secondary	Definite or probable stent thrombosis	Definite or probable stent thrombosis will be evaluated at 48 hours from index procedure	48 hours
Secondary	BARC bleeding	BARC bleeding (type 2,3 and 5) will be evaluated at 48 hours from index procedure	48 hours
Secondary	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
Secondary	Death	All-cause of death will be evaluated at 30 days from index procedure	30 days
Secondary	Myocardial infarction	Recurrent myocardial infarction will be evaluated at 30 days from index procedure	30 days
Secondary	Stroke	Stroke will be evaluated at 30 days from index procedure	30 days
Secondary	Target Vessel Revascularization	Target Vessel Revascularization will be evaluated at 30 days from index procedure	30 days
Secondary	Definite or probable stent thrombosis	Definite or probable stent thrombosis will be evaluated at 30 days from index procedure	30 days
Secondary	BARC bleeding	BARC bleeding will be evaluated at 30 days from index procedure	30 days
Secondary	Cardiac death	Cardiac death will be evaluated at 48 hours from index procedure	48 hours
Secondary	Cardiac death	Cardiac death will be evaluated at 30 days from index procedure	30 days
Secondary	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