Medication for inhibition of activation of a certain immune cell in atherosclerotic lesions

Phase 1

• Conditions: Atherosclerosis; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-002452-16-NL
• Lead Sponsor: MC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-04
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
(1) Patient is 18 years of age or older
(2) Patient is able and willing to give their consent and sign an informed consent
(3) Symptomatic or asymptomatic carotid artery stenosis based on atherosclerosis of at least 50% calculated by using criteria equivalent to the NASCET method
(4) Revascularization through carotid endarterectomy is indicated by multidisciplinary panel
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
(1) Previous anaphylactic reaction (e.g. food allergy, medication such as antibiotics etc.)
(2) Previous CEA or CAS in the ipsilateral artery
(3) Patients with severe asthma or chronic urticaria which are treated or have been treated with omalizumab s.c.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified