E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Calcifications of the arteries |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
One month after treatment with colchicine |
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E.5.2 | 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
One month after treatment with colchicine |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Optical medical therapy (no intervention) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |