Dutch Cangrelor Registry

Completed

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

• Registration Number: NCT04138641
• Lead Sponsor: Isala

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-24
• Study Start: 2019-12-17
• Status Verified: 2020-07
• Primary Completion: 2020-07-24
• Study Completion: 2020-07-24
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

R.S. Hermanides; 🇳🇱 Zwolle, Overijssel, Netherlands