Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Campania Luigi Vanvitelli | OTHER |
Not provided
Not provided
Not provided
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.
Cangrelor administration is currently recommended by international guidelines in patients undergoing PCI who are naĂ¯ve 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High bleeding risk | Patients treated with cangrelor who met the Academic Research Consortium (ARC) definition of high bleeding risk (HBR) |
| |
| Non-high bleeding risk | Patients treated with cangrelor who did not meet the Academic Research Consortium (ARC) definition of high bleeding risk (HBR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cangrelor | Drug | Cangrelor administration during percutaneous coronary intervention for both chronic or acute coronary syndromes |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
1. Cangrelor administration as a bridge to surgery
Not provided
Not provided
Not provided
Consecutive patients undergoing percutaneous coronary intervention with cangrelor infusion will be included.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Italo Porto, MD, PhD | Contact | +39 0105555830 | italo.porto@unige.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UniversitĂ degli Studi della Campania "Luigi Vanvitelli" | Recruiting | Caserta | 81100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39284439 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
Not provided
Not provided
| ID | Term |
|---|---|
| C117446 | cangrelor |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
| University of Genoa | Recruiting | Genova | 16132 | Italy |
|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |