Antiplatelet Therapy in Chronic Urticaria

NCT06268470 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: Chula-ARC 001/18
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the combination of antiplatelets and antihistamine versus antihistamine alone for the treatment of chronic spontaneous urticaria

Conditions

Chronic Urticaria

Keywords

Chronic urticaria; antiplatelet; D-dimer

Outcome Measures

Primary Outcomes (1)

• Weekly urticaria activity score

  Urticaria activity score over 7 days (UAS7): scores 0-42 from mild to severe

  4 weeks

Secondary Outcomes (1)

• D-dimer levels

  4 weeks

Study Arms (2)

Desloratadine

ACTIVE COMPARATOR

Oral desloratadine 20 mg/day (antihistamine) for 4 weeks

Drug: Desloratadine

Desloratadine plus cilostazol and dipyridamole

EXPERIMENTAL

Oral desloratadine 20 mg/day (antihistamine) in conjunction with cilostazol 150 mg/day and dipyridamole 50 mg/day (antiplatelets) for 4 weeks

Drug: Desloratadine plus cilostazol and dipyridamole; Drug: Desloratadine

Interventions

Desloratadine plus cilostazol and dipyridamole DRUG

Desloratadine 20 mg/day plus cilostazol 150 mg/day and dipyridamole 50 mg/day

Also known as: Antihistamine plus antiplatelets

Desloratadine plus cilostazol and dipyridamole

Desloratadine DRUG

Desloratadine 20 mg/day

Also known as: Antihistamine alone

Desloratadine; Desloratadine plus cilostazol and dipyridamole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic spontaneous urticaria
• D-dimer levels over 500 ng/ml
• Not respond to a conventional dose of antihistamine

You may not qualify if:

• Are taking aspirin
• Have bleeding tendency
• Have concurrent severe medical illnesses

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Chronic Urticaria

Interventions

desloratadine; Cilostazol; Dipyridamole; Histamine Antagonists

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrimidines; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Jettanong Klaewsongkram, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Identical capsules
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Jettanong Klaewsongkram, MD.

Model Details: Patients diagnosed with chronic urticaria will be assigned to 2 treatment arms. 1. high dose antihistamine with antiplatelets; and 2. high dose antihistamine alone.

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 20, 2024
• Study Start: June 1, 2018
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)