| Trial ID: | L7019 |
| Source ID: | NCT03376698
|
| Associated Drug: |
Colchicine 0.5 Mg
|
| Title: |
Dose-finding Study of Colchicine in Type 2 Diabetic Patients With Coronary Artery Disease
|
| Acronym: |
DRC-04
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Colchicine|Diabetes Mellitus, Type 2|Coronary Artery Disease|White Blood Cell|Inflammation|Diarrhea
|
| Interventions: |
DRUG: Colchicine 0.5 mg|DRUG: Colchicine 0.25 mg|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in serum high-sensitivity CRP (mg/dl), 4 weeks | Secondary: Change in serum high-sensitivity CRP (mg/dl), 12 weeks|Change in Flow Mediated Dilatation (%), 12 weeks|Change in adhesive ability of white blood cell (number/field of view), 4 weeks|Change in time through the microchannel of white blood cell (sec), 4 weeks|Change in plasma myeloperoxidase level (ng/ml), 4 and 12 weeks | Other: Cardiovascular events, death, myocardial infarction, stroke, hospitalization due to worsening heart failure, unstable angina, 12 weeks|Adverse events, 12 weeks|Side effect, 12 weeks|Diarrhea, especially notable adverse event, 12 weeks|Concentration of colhicine in plasma (ng/ml), feasible facility only, 12 weeks|Concentration of colhicine in white blood cell (ng/1*10^9 cells), feasible facility only, 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: University of the Ryukyus
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
54
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-06-15
|
| Completion Date: |
2022-04-01
|
| Results First Posted: |
|
| Last Update Posted: |
2022-05-12
|
| Locations: |
Hiroshima University Hospital, Hiroshima, Japan|Kitasato University Hospital, Kanagawa, Japan|Urasoe Sogo Hospital, Okinawa, Japan|Dokkyo Medical University Nikko Medical Center, Tochigi, Japan|Showa University Hospital, Tokyo, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT03376698
|
