Atherosclerotic Vascular Disease Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Colchicine on Vascular Inflammation as Assessed With Position Emission Tomography (PET) Imaging in Patients With Atherosclerotic Vascular Disease (COLPET)
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.
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).
;
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 |