The effect of colchicine in patients with atherosclerosis of the heart vessels on white blood cells stimulated with crystals

Phase 1

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

• Registration Number: EUCTR2020-000656-35-NL
• Lead Sponsor: Radboud University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-25
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•Have suffered from type 1 myocardial infarction
•Have been clinically stable for at least three months
•Provided written informed consent

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Age below 18 years
•Use of CYP3A4 or P-glycoprotein inhibitors such as macrolids (claritromycin and erytromycin), ciclosporin, ketoconazol, itraconazol, voriconazol, HIV protease inhibitors, calciumchannel antagonists such as verapamil and diltiazem
•Women who are pregnant, breast feeding or may be considering pregnancy during the study period
•Have renal impairment as evidenced by a serum creatinine >150 µmol/l or eGFR <50mL/min/1.73m2)
•Have an elevated inflammatory profile as evidenced by a hsCRP >10mg/l
•Malignant disease in past five years or any medical condition that could interfere with the conduct of the study in the opinion of the investigator.
•Chronic or recent (<1 month) infections and/or clinical signs of acute infection
•Suffering from auto-immune / inflammatory diseases
•Chronic use of immunosuppressants or anti-inflammatory drugs, including colchicine
•A history of haematological malignant disease
•Recent hospital admission or surgery with general anaesthesia (<3 months)
•Previous vaccination within 1 month prior to study entry
•Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
•Are currently enrolled in a competing trial

Study & Design

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