Coronary Artery Disease, NSTEMI - Non-ST Segment Elevation MI, STEMI - ST Elevation Myocardial Infarction
Conditions
Brief summary
Cangrelor is a fast and directly acting platelet aggregation inhibitor. It is potentially indicated for several types of patients who are undergoing PCI. A nationwide cangrelor registry has up until now not been performed and with the introduction of cangrelor in the Netherlands its efficacy and safety will be determined.
Interventions
DRUGCangrelor
Cangrelor intravenous
Sponsors
Isala
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Inclusion criteria
* Age ≥18 years * One of the following criteria: * Patients naïve for P2Y12 inhibition undergoing PCI * Patients with suboptimal P2Y12 inhibition undergoing PCI (patients who vomited after P2Y12 loading, out of hospital cardiac arrest (OHCA) patients with restoration of spontaneous circulation (ROSC), patients loaded with P2Y12 inhibitors though platelet inhibition still insufficient (\<2 hours after oral loading dose) * (N)STEMI patients loaded with P2Y12 inhibitors with large thrombus burden (thrombus grade 4 or 5) on initial coronary angiography (CAG) and undergoing primary PCI with expected insufficient P2Y12 inhibition
Exclusion criteria
* Patients on current/chronic treatment with P2Y12 inhibitors * Patients (pre) treated with a GPI * Patients with recent major bleeding complications or contraindication to dual antiplatelet therapy: * hypersensitivity or allergy to and known contra-indication for aspirin, clopidogrel, ticagrelor or cangrelor * history of major clinical bleeding or known coagulopathy * active bleeding * history of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke * known severe liver dysfunction * Patients that received any organ transplant or are on a waiting list for any organ transplant * Patients undergoing dialysis * Pregnant or lactating female * Patients currently participating in another investigational drug or device study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NACE | 48 hours | The primary efficacy and safety endpoint is 48 hours Net Adverse Clinical Events (NACE), which is a composite endpoint of all-cause death (including cardiac death), recurrent myocardial infarction, target vessel revascularization, stroke, definite or probable stent thrombosis and bleeding (BARC type 2-5). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NACE 30 days | 30 days | Net Adverse Clinical Events (NACE), which is a composite endpoint of all-cause death (including cardiac death), recurrent myocardial infarction, target vessel revascularization, stroke, definite or probable stent thrombosis and bleeding (BARC type 2-5). |
| All individual endpoints in-hospital | In-hospital, mostly up to 72 hours. | All individual endpoints in-hospital |
| All individual endpoints at 30-days | 30 days | All individual endpoints at 30-days |
| TIMI 3 flow post PCI based on angiographic results | post-PCI, mostly up to 1 hour | TIMI 3 flow post PCI |
Countries
Netherlands
Outcome results
None listed