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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54785

Enrollment

Registered

2019-12-27

Start date

2023-10-01

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

carotid narrowing

Interventions

Intervention: a single treatment moment three days before carotid endarterectomy, patients will receive a total of four subcutaneous injections with omalizumab of 150mg (1.2mL) each. Control interv

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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 planned routinely.

Exclusion criteria

Exclusion criteria: Any anaphylactic reaction in the medical history

Design outcomes

Primary

Measure	Time frame
The primary endpoint is activated mast cell as the percentage of the total mast cell (CD45+CD117+FcR+ cells) count, determined by flow cytometry. Normal unactivated mast cells are positive for the markers CD45, CD117 and FcR. In addition, activated mast cells are positive for IgE and the activationmarkers CD203c and CD63. The primary study parameter is the % of mast cell activation determined by flow cytometry.	—

Measure

Time frame

The primary endpoint is activated mast cell as the percentage of the total mast cell (CD45+CD117+Fc*R+ cells) count, determined by flow cytometry. Normal unactivated mast cells are positive for the markers CD45, CD117 and Fc*R. In addition, activated mast cells are positive for IgE and the activationmarkers CD203c and CD63. The primary study parameter is the % of mast cell activation determined by flow cytometry.

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Secondary

Measure	Time frame
Secondary endpoints are (endpoints will be compared between treatment groups and for point 2,3,5 and 6 between baseline and day 3): (1) Local inflammatory status of atherosclerotic plaque (measuring T-cell subsets, M1/M2 macrophages, neutrophils and B-cells counts) (2) Plasma tryptase levels (3) Level of infection parameters (complete blooudcount, hsCRP, IL-1beta and IL-6) (4) Plaque characterization (using histology) (5) Serum IgE levels (6) Basophil activation status	—

Measure

Time frame

Secondary endpoints are (endpoints will be compared between treatment groups and for point 2,3,5 and 6 between baseline and day 3): (1) Local inflammatory status of atherosclerotic plaque (measuring T-cell subsets, M1/M2 macrophages, neutrophils and B-cells counts) (2) Plasma tryptase levels (3) Level of infection parameters (complete blooudcount, hsCRP, IL-1beta and IL-6) (4) Plaque characterization (using histology) (5) Serum IgE levels (6) Basophil activation status

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)