BleedingICARUSNCT05505591
Intravenous CAngrelor in High-bleeding Risk Patients Undergoing percutaneouS Coronary Intervention (ICARUS) Registry
An observational study of Bleeding and Coronary Artery Disease, run by Universita degli Studi di Genova at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding, Coronary Artery Disease, Myocardial Infarction
- What is being tested?
- Cangrelor
- How many people
- 900 participants
- Where
- 2 sitesItaly
- Study dates
- 6 Jun 2022to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients undergoing percutaneous coronary intervention with cangrelor infusion will be included.
Who may be able to join
- Age ≥ 18 years
- Cangrelor administration during percutaneous coronary intervention for both acute and chronic coronary syndromes
Who cannot join
- 1. Cangrelor administration as a bridge to surgery
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Università degli Studi della Campania "Luigi Vanvitelli"
Caserta, 81100
Paolo Calabrò, MD, PhD
Paolo Calabrò, MD, PhD
- Recruiting
University of Genoa
Genova, 16132
Italo Porto, MD, PhD, +39 0105555830, italo.porto@unige.it
Italo Porto, MD, PhD
About this study
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)
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.
Read the 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
- Being tested
- Cangrelor
- Keywords
- Percutaneous coronary intervention, Cangrelor, High bleeding risk, Coronary artery disease, Acute myocardial infarction
- Medical subject headings
- Hemorrhage, Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CangrelorDrug
Cangrelor administration during percutaneous coronary intervention for both chronic or acute coronary syndromes
| Study group | Role | What they receive |
|---|---|---|
| High bleeding risk | Patients treated with cangrelor who met the Academic Research Consortium (ARC) definition of high bleeding risk (HBR) Receives: Drug: Cangrelor | |
| Non-high bleeding risk | Patients treated with cangrelor who did not meet the Academic Research Consortium (ARC) definition of high bleeding risk (HBR) Receives: Drug: Cangrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of NACE
A composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium 2-5 bleeding
Measured: 48 hours
Secondary outcomes (15)
Rate of MACE
A composite of cardiovascular death, myocardial infarction, stroke and definite or probable stent thrombosis
Measured: 48 hours
Rate of cardiovascular death
Cardiovascular death according to the ARC definition
Measured: 48 hours
Rate of myocardial infarction (periprocedural)
Myocardial infarction (periprocedural) according to the 4th Universal definition
Measured: 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
Measured: 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
Measured: 48 hours
Rate of definite or probable stent thrombosis
Definite or probable stent thrombosis according to the ARC definition
Measured: 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
Measured: 48 hours
Rate of bleeding Academic Research Consortium (BARC) 3 and 5 bleeding
Bleeding grade 3 and 5 according to the ARC definition
Measured: 48 hours
Rate of MACE
A composite of cardiovascular death, myocardial infarction, stroke and definite or probable stent thrombosis
Measured: During hospital stay (up to discharge day), on average 5 days
Rate of cardiovascular death
Cardiovascular death according to the ARC definition
Measured: During hospital stay (up to discharge day), on average 5 days
Rate of myocardial infarction
Myocardial infarction according to the 4th Universal definition
Measured: 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
Measured: 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
Measured: 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
Measured: During hospital stay (up to discharge day), on average 5 days
Rate of blood transfusion
Blood transfusion during hospital stay
Measured: During hospital stay (up to discharge day), on average 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start6 Jun 2022
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita degli Studi di Genova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli
- Responsible party
- Principal investigator, Italo Porto, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505591
- Sponsor's protocol ID
- ICARUS
- Acronym
- ICARUS
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39284439
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05505591
- Acronym / sponsor ID
- ICARUS / ICARUS
- Conditions
- Bleeding, Coronary Artery Disease, Myocardial Infarction
- Keywords
- Percutaneous coronary intervention, Cangrelor, High bleeding risk, Coronary artery disease, Acute myocardial infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Universita degli Studi di GenovaUniversity, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High bleeding risk | – | Drug: CangrelorPatients treated with cangrelor who met the Academic Research Consortium (ARC) definition of high bleeding risk (HBR) |
| Non-high bleeding risk | – | Drug: CangrelorPatients treated with cangrelor who did not meet the Academic Research Consortium (ARC) definition of high bleeding risk (HBR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing percutaneous coronary intervention with cangrelor infusion will be included.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Cangrelor administration during percutaneous coronary intervention for both acute and chronic coronary syndromes
Key exclusion criteria (1 listed)
- 1. Cangrelor administration as a bridge to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CangrelorCangrelor administration during percutaneous coronary intervention for both chronic or acute coronary syndromes | Drug | High bleeding risk, Non-high bleeding risk |
Primary outcome
Rate of NACE
Time frame: 48 hours
A composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium 2-5 bleeding
15 secondary outcomes
Rate of MACE
Time frame: 48 hours
Rate of cardiovascular death
Time frame: 48 hours
Rate of myocardial infarction (periprocedural)
Time frame: 48 hours
Rate of ischemic stroke
Time frame: 48 hours
Rate of hemorrhagic stroke
Time frame: 48 hours
Rate of definite or probable stent thrombosis
Time frame: 48 hours
Rate of bleeding Academic Research Consortium (BARC) 2,3 and 5 bleeding
Time frame: 48 hours
Rate of bleeding Academic Research Consortium (BARC) 3 and 5 bleeding
Time frame: 48 hours
Rate of MACE
Time frame: During hospital stay (up to discharge day), on average 5 days
Rate of cardiovascular death
Time frame: During hospital stay (up to discharge day), on average 5 days
Rate of myocardial infarction
Time frame: During hospital stay (up to discharge day), on average 5 days
Rate of ischemic stroke
Time frame: During hospital stay (up to discharge day), on average 5 days
Rate of hemorrhagic stroke
Time frame: During hospital stay (up to discharge day), on average 5 days
Rate of definite or probable stent thrombosis
Time frame: During hospital stay (up to discharge day), on average 5 days
Rate of blood transfusion
Time frame: During hospital stay (up to discharge day), on average 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Derived from this study: PubMed 39284439Benenati 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding and Coronary Artery Disease, run by Universita degli Studi di Genova at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Italo Porto, MD, PhD (+39 0105555830, italo.porto@unige.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of NACE (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05505591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.