A randomized, double-blind, placebo-controlled phase II trial to evaluate the dose-dependent effect of colchicine on inflammatory response and endothelial function in type 2 diabetic patients with coronary artery disease and leukocyte activatio

Not Applicable

• Conditions: type 2 diabetic patients with coronary artery disease

• Registration Number: JPRN-UMIN000029170
• Lead Sponsor: niversity of the Ryukyus Graduate School of Medicine Clinical Pharmacology and Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-20
• Study Completion: 2022-04-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

(1)Patients with prior hypersensitivity to Colhicine. (2)Patients with taking Colhicine presently or to 30 days before confirmation tests of eligibility. (3)Patients with liver cirrhosis (4)Patients with clinical cholestasis. (5)Patients with decreasing renal function (eGFR < 30 mL/min/1.73m2) at confirmation tests of eligibility. (6)Patients with active malignancy. (7)Patients taking drugs that are indicated as "combined caution" in the package insert of Colchicine as a drug which may interact with Colchicine. 1. Drugs inhibiting cytochrome P450 drug-metabolizing enzyme a. Strong Inhibitor Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Ritonavir, Saquinavir, Darunavir, Telithromycin, Telaprevir, Preparation including Cobicistat b. Moderate Inhibitor Amprenavir, Aprepitant, Diltiazem, Erythromycin, Fluconazole, Fosamprenavir, Verapamil 2. P-glycoprotein inhibitor Ciclosporin (8)Patients taking Amiodarone or Quinidine. (9)Patients with infectious or inflammatory disease at confirmation tests of eligibility. (10)Current smoker (11)Patients with pregnancy, possible pregnancy, on breast-feeding or who wish to become pregnant during trial. (The female subjects who had possibility of pregnancy receive a pregnancy test.) (12)Patients registered in other clinical trials presently or within 30 days before acquisition consent of this trial. (13)Patients whom physician in charge considered inappropriate for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
High sensitive-CRP at 4 weeks