Dutch Cangrelor Registry

Overview

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.

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 24, 2020

Interventions

  • Drug: Cangrelor
    • Cangrelor intravenous

Clinical Trial Outcome Measures

Primary Measures

  • NACE
    • Time Frame: 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 Measures

  • NACE 30 days
    • Time Frame: 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
    • Time Frame: In-hospital, mostly up to 72 hours.
    • All individual endpoints in-hospital
  • All individual endpoints at 30-days
    • Time Frame: 30 days
    • All individual endpoints at 30-days
  • TIMI 3 flow post PCI based on angiographic results
    • Time Frame: post-PCI, mostly up to 1 hour
    • TIMI 3 flow post PCI

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 110 Years

Investigator Details

  • Lead Sponsor
    • Isala
  • Provider of Information About this Clinical Study
    • Principal Investigator: A.H. Tavenier, R.S. Hermanides, Principal investigator – Isala

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