Dutch Cangrelor Registry

Coronary Artery Disease Clinical Trial

Official title:

Dutch Cangrelor Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04138641
• Other study ID #: Dutch Cangelor registry
• Status: Completed
• Start date: December 17, 2019
• Est. completion date: July 24, 2020

Study information

• Verified date: July 2020
• Source: Isala
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 24, 2020
• Est. primary completion date: July 24, 2020
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Cangrelor
Cangrelor intravenous

Locations

Country	Name	City	State
Netherlands	R.S. Hermanides	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Isala

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NACE	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).	48 hours
Secondary	NACE 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).	30 days
Secondary	All individual endpoints in-hospital	All individual endpoints in-hospital	In-hospital, mostly up to 72 hours.
Secondary	All individual endpoints at 30-days	All individual endpoints at 30-days	30 days
Secondary	TIMI 3 flow post PCI based on angiographic results	TIMI 3 flow post PCI	post-PCI, mostly up to 1 hour