Dutch Cangrelor Registry

NCT04138641 | Completed FDA Drug

• 1 other identifier: Dutch Cangelor registry
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• NACE 30 days

  30 days

• All individual endpoints in-hospital

  In-hospital, mostly up to 72 hours.

• All individual endpoints at 30-days

  30 days

• TIMI 3 flow post PCI based on angiographic results

  post-PCI, mostly up to 1 hour

Interventions

Cangrelor DRUG

Cangrelor intravenous

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing (primary) PCI

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isala: lead

Study Sites (1)

R.S. Hermanides

Zwolle, Overijssel, 8025AB, Netherlands

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Coronary Artery Disease

Interventions

cangrelor

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: R.S. Hermanides, Principal investigator

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 24, 2019
• Study Start: December 17, 2019
• Primary Completion: July 24, 2020
• Study Completion: July 24, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)