Inhibition of Mast cell Activation in AtheroScleroTic lesions using an Anti-IgE antibody approach (MAST)

Phase 1

• Conditions: Carotid artery stenosis; MedDRA version: 24.1Level: LLTClassification code: 10029992Term: Occlusion and stenosis of carotid artery Class: 10029205; MedDRA version: 21.1Level: LLTClassification code: 10081245Term: External carotid artery stenosis Class: 10029205; MedDRA version: 20.0Level: PTClassification code: 10007687Term: Carotid artery stenosis Class: 100000004852; MedDRA version: 21.1Level: LLTClassification code: 10081244Term: Internal carotid artery stenosis Class: 10029205; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2024-513581-19-00
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-10
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patient is 18 years or age or older., Patient is able and willing to give their consent and sign an informed consent., Patient has a symptomatic or asymptomatic atherosclerotic carotid artery stenosis of at least 50% narrowing of the lumen (calculated by using criteria equivalent to the NASCET method) wherefore revascularisation through carotid endarterectomy is plannend routinely.

Exclusion Criteria

Previous anaphylactic reaction (e.g. food allergy, medication such as antibiotics), Previous carotid endarterectomy (CEA) or carotid artery stenting (CAS) in the ipsilateral artery., Patients with severe asthma or chronic urticaria which are treated or have been treated with omalizumab subcutaneously.

Study & Design

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