Atherosclerosis
Conditions
Interventions
Trade Name: Colchicine 0.5mg Tiofarma
Pharmaceutical Form: Tablet
Sponsors
Radboud University Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess changes in inflammatory cytokine release of monocytes and neutrophils stimulated with cholesterol crystals, isolated from patients with chronic coronary artery disease after colchicine 0.5mg daily during one month, compared to no colchicine treatment;Secondary Objective: Secondary objective: To assess whether hsCRP change in serum correlates with change in cytokine release by monocytes and neutrophils stimulated with MSU crystals, isolated from patients with chronic coronary artery disease after colchicine 0.5mg daily during one month Tertiary objective: To assess changes of RNA expression in CD14+ monocytes, isolated from patients with chronic coronary artery disease after colchicine 0.5mg daily during one month, compared to no colchicine treatment. ;Primary end point(s): The change in inflammatory cytokine release of monocytes and neutrophils, after stimulation with MSU crystals, isolated before versus after treatment with low dose colchicine of 0.5mg daily during one month, compared to no colchicine treatment;Timepoint(s) of evaluation of this end point: One month after treatment with colchicine | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objective: Correlation between change in serum hsCRP and change in cytokine release of monocytes and neutrophils after stimulation with MSU crystals after one month of colchicine treatment 0.5mg once daily Tertiary objective: Changes in RNA expression in CD14+ monocytes, isolated from patients with chronic coronary artery disease before versus after colchicine 0.5mg daily during one month, compared to no colchicine treatment. ;Timepoint(s) of evaluation of this end point: One month after treatment with colchicine | — |
Countries
Netherlands
Contacts
Public ContactTjerk Opstal
Radboud University Medical Centre
Outcome results
None listed