Dutch Cangrelor Registry

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease; NSTEMI - Non-ST Segment Elevation MI; STEMI - ST Elevation Myocardial Infarction
• Intervention / Treatment: Drug: Cangrelor

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025AB
      • R.S. Hermanides

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing (primary) PCI

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Isala

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 17, 2019
• Primary Completion (ACTUAL): July 24, 2020
• Study Completion (ACTUAL): July 24, 2020

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (ACTUAL): October 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; ST Elevation Myocardial Infarction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Cangrelor
• Other Study ID Numbers: Dutch Cangelor registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No