Intravenous CAngrelor in High-bleeding Risk Patients Undergoing percutaneouS Coronary Intervention (ICARUS) Registry

NCT ID: NCT05505591

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-06
• Study Completion Date: 2022-10-31

Brief Summary

The study will investigate the prevalence of high bleeding risk (HBR) features and will compare the clinical outcomes of HBR and non-HBR patients among those undergoing percutaneous coronary intervention and receiving cangrelor infusion.

Detailed Description

Cangrelor administration is currently recommended by international guidelines in patients undergoing PCI who are naïve to P2Y12 inhibitors. These recommendations are based on the large Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION) program, which encompassed three randomized controlled trials (RCTs) enrolling both chronic and acute coronary syndromes. Consistently, the aforementioned studies showed the benefit of cangrelor in terms of ischemic events (mainly driven by a reduction of myocardial infarction - MI - and stent thrombosis - ST) in the face of an increased rate of minor bleeding. However, those RCTs were primarily focused on populations at considerable ischemic risk and with predictably low bleeding proneness, including young patients without bleeding risk features.

In the contemporary practice, however, PCI is increasingly frequent in patients at high risk of bleeding, who are not formally prevented from being administered with cangrelor by international guidelines and possibly necessitate powerful and rapid-onset platelet inhibition while undergoing complex percutaneous revascularization. The present registry was therefore conceived at the scope of collecting data on the use of cangrelor in high bleeding risk (HBR) patients undergoing contemporary PCI. Specifically, it will assess the frequency of HBR patients in a real-world cohort of individuals treated with cangrelor and will compare the clinical outcomes of HBR and non-HBR patients.

Conditions

Bleeding; Coronary Artery Disease; Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

High bleeding risk

Patients treated with cangrelor who met the Academic Research Consortium (ARC) definition of high bleeding risk (HBR)

Cangrelor

Intervention Type: DRUG

Cangrelor administration during percutaneous coronary intervention for both chronic or acute coronary syndromes

Non-high bleeding risk

Patients treated with cangrelor who did not meet the Academic Research Consortium (ARC) definition of high bleeding risk (HBR)

Cangrelor

Intervention Type: DRUG

Cangrelor administration during percutaneous coronary intervention for both chronic or acute coronary syndromes

Interventions

Cangrelor

Cangrelor administration during percutaneous coronary intervention for both chronic or acute coronary syndromes

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years

2. Cangrelor administration during percutaneous coronary intervention for both acute and chronic coronary syndromes

Exclusion Criteria

1. Cangrelor administration as a bridge to surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: collaborator

Universita degli Studi di Genova

OTHER

Sponsor Role: lead

Responsible Party

Italo Porto

Full Professor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Università degli Studi della Campania "Luigi Vanvitelli"

Caserta, , Italy

Site Status: RECRUITING

University of Genoa

Genova, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Italo Porto, MD, PhD

Role: CONTACT

italo.porto@unige.it

+39 0105555830

Facility Contacts

Paolo Calabrò, MD, PhD

Role: primary

Italo Porto, MD, PhD

Role: primary

italo.porto@unige.it

+39 0105555830

References

Benenati S, Gragnano F, Scalamera R, De Sio V, Capolongo A, Cesaro A, Annibali G, Campagnuolo S, Silverio A, Bellino M, Centore M, Schettino M, Bertero E, Caretta G, Rezzaghi M, Veneziano F, De Nardo D, De Rosa G, De Luca L, Galasso G, Menozzi A, Musumeci G, Cirillo P, Calabro P, Porto I. ICARUS score for predicting peri-procedural bleeding in patients undergoing percutaneous coronary intervention with cangrelor. Int J Cardiol. 2024 Dec 15;417:132568. doi: 10.1016/j.ijcard.2024.132568. Epub 2024 Sep 14.

Reference Type: DERIVED

PMID: 39284439 (View on PubMed)

Other Identifiers

ICARUS

Identifier Type: -

Identifier Source: org_study_id