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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Coronary Artery Disease; Bleeding
• Intervention / Treatment: Drug: Cangrelor

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 Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

• Study Contact: Name: Italo Porto, MD, PhD; Phone Number: +39 0105555830; Email: italo.porto@unige.it

Study Locations

• Italy
  • Caserta, Italy, 81100
    • Recruiting
    • Universita degli Studi della Campania "Luigi Vanvitelli"
    • Contact: Paolo Calabrò, MD, PhD
    • Sub-Investigator: Felice Gragnano, MD, PhD
  • Genova, Italy, 16132
    • Recruiting
    • University of Genoa
    • Contact: Italo Porto, MD, PhD; Phone Number: +39 0105555830; Email: italo.porto@unige.it
    • Principal Investigator: Italo Porto, MD, PhD
    • Sub-Investigator: Stefano Benenati, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients undergoing percutaneous coronary intervention with cangrelor infusion will be included.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High bleeding risk; Patients treated with cangrelor who met the Academic Research Consortium (ARC) definition of high bleeding risk (HBR)	Drug: Cangrelor; 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)	Drug: Cangrelor; Cangrelor administration during percutaneous coronary intervention for both chronic or acute coronary syndromes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of MACE	A composite of cardiovascular death, myocardial infarction, stroke and definite or probable stent thrombosis	48 hours
Rate of cardiovascular death	Cardiovascular death according to the ARC definition	48 hours
Rate of myocardial infarction (periprocedural)	Myocardial infarction (periprocedural) according to the 4th Universal definition	48 hours
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
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
Rate of definite or probable stent thrombosis	Definite or probable stent thrombosis according to the ARC definition	48 hours
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
Rate of bleeding Academic Research Consortium (BARC) 3 and 5 bleeding	Bleeding grade 3 and 5 according to the ARC definition	48 hours
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
Rate of cardiovascular death	Cardiovascular death according to the ARC definition	During hospital stay (up to discharge day), on average 5 days
Rate of myocardial infarction	Myocardial infarction according to the 4th Universal definition	During hospital stay (up to discharge day), on average 5 days
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
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
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
Rate of blood transfusion	Blood transfusion during hospital stay	During hospital stay (up to discharge day), on average 5 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of all-cause death	All-cause death	48 hours
Rate of thrombolysis in myocardial infarction (TIMI) major bleeding	Major bleeding according to the TIMI definition	48 hours
Rate of thrombolysis in myocardial infarction (TIMI) minor bleeding	Minor bleeding according to the TIMI definition	48 hours
Rate of all-cause death	All-cause death	During hospital stay (up to discharge day), on average 5 days
Rate of all-cause death	All-cause death	Through the longest available follow-up, an average of 1 year

Collaborators and Investigators

• Sponsor: Universita degli Studi di Genova
• Collaborators: Università degli Studi della Campania Luigi Vanvitelli

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Coronary artery disease; Percutaneous coronary intervention; Acute myocardial infarction; Cangrelor; High bleeding risk
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hemorrhage; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Cangrelor
• Other Study ID Numbers: ICARUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No