Colchicine in Vascular Inflammation Assessed With PET Imaging (COLPET)
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|ClinicalTrials.gov Identifier: NCT02162303|
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : February 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerotic Vascular Disease||Drug: Colchicine Drug: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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)|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||January 2016|
Colchicine 0.6 mg tablets,once daily, for 6 months
0.6 mg a day of active treatment or placebo for 24 weeks
Other Name: Colchicum autumnale
Placebo Comparator: Placebo
Sugar,given once daily, over 6 months.To mimic active treatment.
Sugar,given once daily, over 6 months.To mimic active treatment
Other Name: Sugar
- Change in the average of maximum target-to-background (TBR) values (Mean MAX TBR) of the ascending aorta [ Time Frame: baseline and 6 months ]
- Change in the Mean Maximum Target-to-background (Mean MAX TBR) of carotid arteries [ Time Frame: baseline and 6 months ]
- Change in the average of the mean TBR values (Mean MEAN TBR) [ Time Frame: baseline and 6 months ]
- Change in the Most Diseased Segment TBR values (MDS TBR) in the carotid arteries and ascending aorta [ Time Frame: baseline and 6 months ]MDS TBR is defined as the 1.5 cm segment that demonstrates the highest PET/CT activity at baseline and is calculated as the Mean Max TBR values derived from approximately 5 contiguous axial segments.
- Change in soluble biomarkers of inflammation [ Time Frame: baseline and 6 months ]Soluble biomarkers of inflammation include high sensitivity C-Reactive Protein (hs-CRP). As well, frozen samples (whole blood, plasma and leucocytes for RNA analyses) will be kept for future use for evaluation of biomarkers related to cardiovascular disease and responses to the treatment mostly regarding: lipid, inflammation and oxidative stress.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162303
|Montreal Heart Institute|
|Montreal, Quebec, Canada, H1T 1C8|
|Principal Investigator:||Jean-Claude Tardif, MD||Montreal Heart Institute|