Dutch Cangrelor Registry

NCT ID: NCT04138641

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-17
• Study Completion Date: 2020-07-24

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.

Conditions

STEMI - ST Elevation Myocardial Infarction; NSTEMI - Non-ST Segment Elevation MI; Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Cangrelor

Cangrelor intravenous

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Isala

OTHER

Sponsor Role: lead

Responsible Party

A.H. Tavenier

R.S. Hermanides, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

R.S. Hermanides

Zwolle, Overijssel, Netherlands

Countries

Netherlands

Other Identifiers

Dutch Cangelor registry

Identifier Type: -

Identifier Source: org_study_id