Clinical trial NCT05505591: Intravenous CAngrelor in High-bleeding Risk Patients Undergoing percutaneouS Coronary Intervention (ICARUS) Registry
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bleeding
Coronary Artery Disease
Myocardial Infarction
Keywords: Percutaneous coronary intervention
Cangrelor
High bleeding risk
Coronary artery disease
Acute myocardial infarction
Lead sponsor: Universita degli Studi di Genova
Sponsor class: OTHER
Collaborators: name: University of Campania Luigi Vanvitelli
First posted: 2022-08-18
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing percutaneous coronary intervention with cangrelor infusion will be included.

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.

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

Primary outcomes:
measure: Rate of NACE
timeFrame: 48 hours
Secondary outcomes:
measure: Rate of MACE
timeFrame: 48 hours
measure: Rate of cardiovascular death
timeFrame: 48 hours
measure: Rate of myocardial infarction (periprocedural)
timeFrame: 48 hours
measure: Rate of ischemic stroke
timeFrame: 48 hours
measure: Rate of hemorrhagic stroke
timeFrame: 48 hours
measure: Rate of definite or probable stent thrombosis
timeFrame: 48 hours
measure: Rate of bleeding Academic Research Consortium (BARC) 2,3 and 5 bleeding
timeFrame: 48 hours
measure: Rate of bleeding Academic Research Consortium (BARC) 3 and 5 bleeding
timeFrame: 48 hours
measure: Rate of MACE
timeFrame: During hospital stay (up to discharge day), on average 5 days
measure: Rate of cardiovascular death
timeFrame: During hospital stay (up to discharge day), on average 5 days
measure: Rate of myocardial infarction
timeFrame: During hospital stay (up to discharge day), on average 5 days
measure: Rate of ischemic stroke
timeFrame: During hospital stay (up to discharge day), on average 5 days
measure: Rate of hemorrhagic stroke
timeFrame: During hospital stay (up to discharge day), on average 5 days
measure: Rate of definite or probable stent thrombosis
timeFrame: During hospital stay (up to discharge day), on average 5 days
measure: Rate of blood transfusion
timeFrame: During hospital stay (up to discharge day), on average 5 days
Other outcomes:
measure: Rate of all-cause death
timeFrame: 48 hours
measure: Rate of thrombolysis in myocardial infarction (TIMI) major bleeding
timeFrame: 48 hours
measure: Rate of thrombolysis in myocardial infarction (TIMI) minor bleeding
timeFrame: 48 hours
measure: Rate of all-cause death
timeFrame: During hospital stay (up to discharge day), on average 5 days
measure: Rate of all-cause death
timeFrame: Through the longest available follow-up, an average of 1 year
Locations:
city: Caserta
country: Italy
facility: Università degli Studi della Campania "Luigi Vanvitelli"
city: Genova
country: Italy
facility: University of Genoa
Study officials:
References: