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Atherosclerotic Vascular DiseasePhase 2COLPETNCT02162303

Colchicine in Vascular Inflammation Assessed With PET Imaging

A Phase 2 study testing Colchicine in people with Atherosclerotic Vascular Disease, run by Montreal Heart Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atherosclerotic Vascular Disease
What is being tested?
Colchicine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
106 participants
Where
1 siteCanada
Study dates
May 2014to Jan 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

Other trials in Canada

About this study

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.

Read the 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).

Being tested
Colchicine, Placebo
Keywords
Atherosclerosis, Vascular, Cardiovascular, Coronary artery disease, Imaging, PET, Scan, anti-inflammatory
Medical subject headings
Atherosclerosis, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ColchicineDrug

    Also called Colchicum autumnale

    0.6 mg a day of active treatment or placebo for 24 weeks

  • PlaceboDrug

    Also called Sugar

    Sugar,given once daily, over 6 months.To mimic active treatment

Study groups in NCT02162303
Study groupRoleWhat they receive
ColchicineExperimentalColchicine 0.6 mg tablets,once daily, for 6 months
Receives: Drug: Colchicine
PlaceboPlacebo comparatorSugar,given once daily, over 6 months.To mimic active treatment.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the average of maximum target-to-background (TBR) values (Mean MAX TBR) of the ascending aorta

    Measured: baseline and 6 months

Secondary outcomes (4)

  1. Change in the Mean Maximum Target-to-background (Mean MAX TBR) of carotid arteries

    Measured: baseline and 6 months

  2. Change in the average of the mean TBR values (Mean MEAN TBR)

    Measured: baseline and 6 months

  3. Change in the Most Diseased Segment TBR values (MDS TBR) in the carotid arteries and ascending aorta

    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.

    Measured: baseline and 6 months

  4. Change in soluble biomarkers of inflammation

    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.

    Measured: baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionJul 2015
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02162303
Sponsor's protocol ID
MHIPS-002
Acronym
COLPET
Status last verified
Feb 2020
First submitted
10 Jun 2014
Last updated
21 Feb 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Colchicine in people with Atherosclerotic Vascular Disease, run by Montreal Heart Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the average of maximum target-to-background (TBR) values (Mean MAX TBR) of the ascending aorta (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02162303.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.

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