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

Coronary Artery Disease Clinical Trial

— ICARUS  

Official title:

Multicenter, Observational, Retrospective Cohort Study of Patients at High Risk of Bleeding Undergoing Percutaneous Coronary Intervention and Treated With Intravenous Cangrelor Infusion (ICARUS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05505591
• Other study ID #: ICARUS
• Status: Recruiting
• Start date: June 6, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: August 2022
• Source: Universita degli Studi di Genova
• Contact: Italo Porto, MD, PhD
• Phone: +39 0105555830
• Email: italo.porto[@]unige.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Coronary Artery Disease
• Coronary Disease
• Hemorrhage
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Italy	Università degli Studi della Campania "Luigi Vanvitelli"	Caserta
Italy	University of Genoa	Genova

Sponsors (2)

Lead Sponsor	Collaborator
Universita degli Studi di Genova	Università degli Studi della Campania Luigi Vanvitelli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of all-cause death	All-cause death	48 hours
Other	Rate of thrombolysis in myocardial infarction (TIMI) major bleeding	Major bleeding according to the TIMI definition	48 hours
Other	Rate of thrombolysis in myocardial infarction (TIMI) minor bleeding	Minor bleeding according to the TIMI definition	48 hours
Other	Rate of all-cause death	All-cause death	During hospital stay (up to discharge day), on average 5 days
Other	Rate of all-cause death	All-cause death	Through the longest available follow-up, an average of 1 year
Primary	Rate of NACE	A composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium 2-5 bleeding	48 hours
Secondary	Rate of MACE	A composite of cardiovascular death, myocardial infarction, stroke and definite or probable stent thrombosis	48 hours
Secondary	Rate of cardiovascular death	Cardiovascular death according to the ARC definition	48 hours
Secondary	Rate of myocardial infarction (periprocedural)	Myocardial infarction (periprocedural) according to the 4th Universal definition	48 hours
Secondary	Rate of ischemic stroke	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	48 hours
Secondary	Rate of hemorrhagic stroke	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	48 hours
Secondary	Rate of definite or probable stent thrombosis	Definite or probable stent thrombosis according to the ARC definition	48 hours
Secondary	Rate of bleeding Academic Research Consortium (BARC) 2,3 and 5 bleeding	Bleeding grade 2,3 and 5 according to the ARC definition	48 hours
Secondary	Rate of bleeding Academic Research Consortium (BARC) 3 and 5 bleeding	Bleeding grade 3 and 5 according to the ARC definition	48 hours
Secondary	Rate of MACE	A composite of cardiovascular death, myocardial infarction, stroke and definite or probable stent thrombosis	During hospital stay (up to discharge day), on average 5 days
Secondary	Rate of cardiovascular death	Cardiovascular death according to the ARC definition	During hospital stay (up to discharge day), on average 5 days
Secondary	Rate of myocardial infarction	Myocardial infarction according to the 4th Universal definition	During hospital stay (up to discharge day), on average 5 days
Secondary	Rate of ischemic stroke	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	During hospital stay (up to discharge day), on average 5 days
Secondary	Rate of hemorrhagic stroke	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	During hospital stay (up to discharge day), on average 5 days
Secondary	Rate of definite or probable stent thrombosis	Definite or probable stent thrombosis according to the ARC definition	During hospital stay (up to discharge day), on average 5 days
Secondary	Rate of blood transfusion	Blood transfusion during hospital stay	During hospital stay (up to discharge day), on average 5 days