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Colchicine in Vascular Inflammation Assessed With PET Imaging (COLPET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162303
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Montreal Heart Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Atherosclerotic Vascular Disease Drug: Colchicine Drug: Placebo Phase 2

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
Experimental: Colchicine
Colchicine 0.6 mg tablets,once daily, for 6 months
Drug: Colchicine
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.
Drug: Placebo
Sugar,given once daily, over 6 months.To mimic active treatment
Other Name: Sugar




Primary Outcome Measures :
  1. Change in the average of maximum target-to-background (TBR) values (Mean MAX TBR) of the ascending aorta [ Time Frame: baseline and 6 months ]

Secondary Outcome Measures :
  1. Change in the Mean Maximum Target-to-background (Mean MAX TBR) of carotid arteries [ Time Frame: baseline and 6 months ]
  2. Change in the average of the mean TBR values (Mean MEAN TBR) [ Time Frame: baseline and 6 months ]
  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients providing informed consent
  • Patient must have evidence of coronary artery disease (CAD) as evidenced by at least one of the following:
  • Angiographic evidence of at least 50% stenosis in one coronary artery (except for left main coronary artery stenosis, in which 30% is acceptable)
  • History of prior percutaneous coronary intervention (PCI)
  • History of prior acute coronary syndrome (ACS) event (ST elevation myocardial infarction (STEMI), non-STEMI or unstable angina)
  • Patient has a carotid or ascending aorta atherosclerotic plaque inflammation TBR of 1.6 or more as determined by 18F-FDG uptake measured by PET scanning
  • Patient must be on a stable dose for at least 8 weeks before baseline if taking medications used to control angina, hypertension, serum lipids (including statins) or any medication that can have an effect on inflammation
  • Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practices a birth control method throughout the study and for 30 days after study completion
  • Patient is judged to be in good general health as determined by the principal investigator
  • Patient must be able and willing to comply with the requirements of this study protocol

Exclusion Criteria:

Poorly controlled medical condition, such as uncontrolled diabetes, documented history of recurrent infections, unstable ischemic heart disease, congestive heart failure, a left ventricular ejection fraction of less than 40%, recent stroke (within the past 3 months), chronic leg ulcer or any other condition which, in the opinion of the investigator, would put the patient at risk if participating in the study

  • History of ACS, PCI, myocardial infarction, carotid revascularization or hospitalization for a cardiac condition within 12 weeks of baseline
  • Prior coronary artery bypass graft
  • Planned change in medical treatment during the study, that can have effect on inflammation, for angina, serum lipids, and other conditions
  • History of cancer or lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
  • History of listeriosis, treated or untreated tuberculosis, persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous anti-infective agent within 30 days or oral anti-infective agent within 14 days prior to baseline
  • Hepatitis B or hepatitis C viral infection
  • Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or patient with chronic diarrhea
  • Pre-existent progressive neuromuscular disease or patient with creatine phosphokinase (CPK) level > 3 times the upper limit of normal at baseline
  • Current use or plans to use anti-retroviral therapy at any time during the study, or with active chronic disease often treated with a protease inhibitor, including AIDS
  • Diagnosed with immune deficiency or as immunocompromised
  • Any of the following: hemoglobin < 120g/L, white blood cell count < 3.0 X 109/L, platelet count <130 X 109/L, Alanine aminotransferase (ALT) > 3 times the upper limit of normal, Aspartate aminotransferase (AST) > 3 times the upper normal limit, total bilirubin > 2 times the upper normal limit, creatinine > 150 umol/L, creatinine clearance < 30 mL/min, or history of cirrhosis or severe hepatic disease
  • Pregnant or breast-feeding or considering becoming pregnant during the study or for 6 months after the last dose of study medication
  • History of clinically significant drug or alcohol abuse in the last year
  • Previous bilateral carotid surgery
  • Other indications for colchicine use (mainly chronic indications represented by Familial Mediterranean Fever or gout)
  • History of an allergic reaction or significant sensitivity to constituents of study drug
  • Use of an investigational chemical agent less than 50 days or 5 half-lives prior to baseline (whichever is longer)
  • Judged by the investigator to be an unsuitable candidate for the study

Information from the National Library of Medicine

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


Locations
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Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Montreal Heart Institute
Investigators
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Principal Investigator: Jean-Claude Tardif, MD Montreal Heart Institute
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Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT02162303    
Other Study ID Numbers: MHIPS-002
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Montreal Heart Institute:
Atherosclerosis
Vascular
Cardiovascular
Coronary artery disease
Imaging
PET
Scan
anti-inflammatory
Additional relevant MeSH terms:
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Vascular Diseases
Atherosclerosis
Inflammation
Pathologic Processes
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents