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

• Conditions: Coronary Artery Disease; Myocardial Infarction; Bleeding
• Interventions: Drug: Cangrelor

• Registration Number: NCT05505591
• Lead Sponsor: Universita degli Studi di Genova

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.

Study Timeline

• Study Start: 2022-06-06
• Status Verified: 2022-08
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-11
• Last Update Submitted: 2022-08-11
• Study First Posted: 2022-08-18
• Last Update Posted: 2022-08-18
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High bleeding risk	Cangrelor	Patients treated with cangrelor who met the Academic Research Consortium (ARC) definition of high bleeding risk (HBR)
Non-high bleeding risk	Cangrelor	Patients treated with cangrelor who did not meet the Academic Research Consortium (ARC) definition of high bleeding risk (HBR)

Primary Outcome Measures

Name	Time	Method
Rate of NACE	48 hours	A composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium 2-5 bleeding

Secondary Outcome Measures

Name	Time	Method
Rate of definite or probable stent thrombosis	During hospital stay (up to discharge day), on average 5 days	Definite or probable stent thrombosis according to the ARC definition
Rate of cardiovascular death	During hospital stay (up to discharge day), on average 5 days	Cardiovascular death according to the ARC definition
Rate of ischemic stroke	During hospital stay (up to discharge day), on average 5 days	An acute episode of focal or global neurological dysfunction caused by central nervous system (CNS) vascular injury as a result of infarction, involving the brain, spinal cord or retina
Rate of blood transfusion	During hospital stay (up to discharge day), on average 5 days	Blood transfusion during hospital stay
Rate of myocardial infarction (periprocedural)	48 hours	Myocardial infarction (periprocedural) according to the 4th Universal definition
Rate of bleeding Academic Research Consortium (BARC) 3 and 5 bleeding	48 hours	Bleeding grade 3 and 5 according to the ARC definition
Rate of myocardial infarction	During hospital stay (up to discharge day), on average 5 days	Myocardial infarction according to the 4th Universal definition
Rate of hemorrhagic stroke	During hospital stay (up to discharge day), on average 5 days	An acute episode of focal or global neurological dysfunction caused by central nervous system (CNS) vascular injury as a result of hemorrhage, involving the brain, spinal cord or retina
Rate of MACE	During hospital stay (up to discharge day), on average 5 days	A composite of cardiovascular death, myocardial infarction, stroke and definite or probable stent thrombosis
Rate of bleeding Academic Research Consortium (BARC) 2,3 and 5 bleeding	48 hours	Bleeding grade 2,3 and 5 according to the ARC definition

Trial Locations

Locations (2)

Università degli Studi della Campania "Luigi Vanvitelli"; 🇮🇹 Caserta, Italy

University of Genoa; 🇮🇹 Genova, Italy