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Clinical Trial Summary

The purpose of this trial is to assess the effects of colchicine on vascular inflammation measured by (FDG)-PET imaging in patients with atherosclerotic vascular disease. This effect will also be measured by soluble plasma biomarkers. Finally, an optional pharmacogenomic investigation will be performed to identify genetic biomarkers of patient response.


Clinical Trial Description

This is an interventional trial targetting patients 18 years old or older with a carotid artery or an ascending aorta to background ration (TBR) of ≥1.6 as determined by 18 fluorodeoxyglucose (18F-FDG) uptake measured by positron emission tomography (PET) as evidence of atherosclerotic plaque inflammation.

Following randomization,patients will be followed over a period of 6 months (24 weeks), through 2 phone contacts at 6 and 20 weeks and 2 on-site visits at 12 and 24 weeks.

Each on-site visits will include blood draws to monitor routine chemistry and hematology,as well as biomarkers and lipid profiles.

Each phone contacts will include monitoring of patient's general health and well-being.

PET imaging will be performed at baseline and at the 24-weeks visit.

Safety in this study will be assessed by clinical laboratory parameters, physical examinations, ECGs, vital signs, and the frequency and intensity of clinical adverse events (AEs).

The Montreal Health Innovations Coordinating Center (MHICC) will be responsible for processing and quality control of the data. Project management will be carried out as described in the MHICC standard operating procedures (SOPs) for clinical studies. The handling of data, including data quality control, will comply with all applicable regulatory guidelines, MHICC SOPs and the study Data Management Plan. As such, a MHICC medical monitor will be appointed to the trial as the serious adverse event reporting contact (24/7). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02162303
Study type Interventional
Source Montreal Heart Institute
Contact
Status Completed
Phase Phase 2
Start date May 2014
Completion date January 2016

See also
  Status Clinical Trial Phase
Completed NCT03829046 - The Effects of Evolocumab in Patients With Diabetes and Atherosclerotic Vascular Disease Phase 4
Completed NCT00703261 - Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED) Phase 1