Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial)

July 22, 2026 updated by: Ottawa Hospital Research Institute

Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis: A Randomized Controlled Pilot Trial

This trial seeks to assess the feasibility of a full-scale, double-blind, placebo-controlled, randomized trial assessing whether low-dose colchicine (0.5 mg daily) reduces the risk of post-thrombotic syndrome (PTS) in patients with proximal lower extremity deep vein thrombosis (DVT).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Eligible and consenting patients will be randomized via a central web-based randomization system (1:1 ratio) to receive one tablet of colchicine 0.5 mg or identical matching placebo daily starting within 7 days of initiation of anticoagulation for acute, symptomatic, proximal lower extremity Deep Vein Thrombosis (DVT) for a treatment course of 180 days (+/- 7 days). Study drug will start within 24 hours of randomization. The type, dose, and duration of anticoagulant therapy : unfractionated heparin, Low Molecular Weight Heparin (LMWH), fondaparinux, Direct Oral Anticoagulation (DOAC) or Vitamin K Agonist (VKA) will be left to the discretion of the treating physician or local investigator. The study drug will be continued until the end of the treatment period (180 days +/- 7 days). All patients will be observed until the end of study follow-up (365 days +/- 7 days).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Marc Carrier, MD,MSc,FRCPC
  • Phone Number: Ext. 73668 6137378899
  • Email: mcarrier@toh.ca

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital General Campus
        • Principal Investigator:
          • Marc Carrier, MD,MSc,FRCPC
        • Contact:
      • Windsor, Ontario, Canada, N8W2X3
        • Recruiting
        • Windsor Regional Hospital
        • Contact:
        • Principal Investigator:
          • Andrea Cervi, MD, MSc, FRCPC,
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Centre de recherche du Centre Hospitalier de l'Universite de Montreal
        • Contact:
        • Principal Investigator:
          • Emmanuelle Duceppe, MD,PhD,FRCPC
      • Montreal, Quebec, Canada, H3T 1E2
        • Not yet recruiting
        • The Sir Mortimer B. Davis Jewish General Hospital
        • Contact:
        • Principal Investigator:
          • Susan Kahn, MD,MSc,FRCPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Consenting patients 18 years of age or older with a first, acute, symptomatic proximal (popliteal vein or more proximal) objectively confirmed DVT of the lower extremity will be eligible to participate in the study.

Exclusion Criteria:

  1. History of an allergic reaction or significant sensitivity to colchicine.
  2. Requirement of colchicine for other indications.
  3. Active or chronic diarrhea, or documented inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis), collagenous colitis or irritable bowel syndrome or existing blood dyscrasias.
  4. Known or suspected, recent (<30 days) or active infections (acute or chronic).
  5. History of cirrhosis, chronic active hepatitis, or severe liver disease.
  6. Recent (<30 days) or chronic use of systemic (oral, intravenous) immunosuppressive drugs (including but not limited to steroids, tumor necrosis factor-alpha blockers, cyclosporine).
  7. Known active cancer.
  8. Any of the following as measured within the past 1-3 months or at screening: alanine, or aspartate aminotransferase >3 times the upper limit of normal, total bilirubin >2 times the upper limit of normal and a creatinine clearance by Cockcroft-Gault formula <30 mL/min.
  9. Pregnancy, breast feeding or may be considering pregnancy during the study period or women of childbearing potential unwilling to use appropriate contraception during sex;
  10. The use of medication with known drug-to-drug interactions (including but not limited to erythromycin or clarithromycin).
  11. Unable or unwilling to provide consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Arm: Colchicine
Colchicine 0.5 mg po once daily for 180 days. After the Day - 180 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.
Drug: Colchicine 0.5 mg po
Colchicine 0.5 mg po once daily for 180 days.
Other Names:
  • Myinfla tablet 0.5 mg po daily
Placebo Comparator: Control Arm : Placebo
Placebo 0.5 mg po once daily for 180 days. After the Day - 180 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.
Drug: Placebo 0.5 mg po
Placebo 0.5 mg po once daily for 180 days.
Other Names:
  • Placebo 0.5 mg po daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pilot Trial Primary Outcome: Recruitment Rate
Time Frame: 12 months
Mean number of participants recruited per site per month
12 months
Full-Scale Trial Primary Outcome: Post Thrombotic Syndrome
Time Frame: 180 days
VILLALTA scale score ≥5 signifies clinically meaningful Post Thrombotic Syndrome
180 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pilot Trial Secondary Outcome: Eligibility Rate
Time Frame: 12 months
Proportion of screened patients who are eligible
12 months
Pilot Trial Secondary Outcome: Consent Rate
Time Frame: 12 months
Proportion of eligible patients who provide consent
12 months
Pilot Trial Secondary Outcome: Retention Rate
Time Frame: 12 months
Proportion of participants retained at follow-up
12 months
Pilot Trial Secondary Outcome: Study Completion Rate
Time Frame: 12 months
Proportion of participants who completed all study procedures
12 months
Pilot Trial Secondary Outcome: Adherence Rate
Time Frame: 12 months
Adherence to study drug measured by pill count at the end of follow-up
12 months
Pilot Trial Secondary Outcome: Reasons for declining participation
Time Frame: 12 months
Pilot Trial Secondary Outcome: Reasons for declining participation
12 months
Full-Scale Trial Secondary Outcome: Recurrent Venous Thromboembolism
Time Frame: 180 and 365 days
Full-Scale Trial Secondary Outcome: Recurrent Venous Thromboembolism
180 and 365 days
Full-Scale Trial Secondary Outcome: Major Bleeding
Time Frame: 180 and 365 days
As per International Society on Thrombosis and Haemostasis (ISTH) definition
180 and 365 days
Full-Scale Trial Secondary Outcome: Clinically Relevant Non-Major Bleeding
Time Frame: 180 and 365 days
As per ISTH definition
180 and 365 days
Full-Scale Trial Secondary Outcome: Overall Mortality
Time Frame: 180 and 365 days
Full-Scale Trial Secondary Outcome: Overall Mortality
180 and 365 days
Full-Scale Trial Secondary Outcome: Incremental Cost-Effectiveness Ratio (ICER)
Time Frame: 180 and 365 days
Full-Scale Trial Secondary Outcome: Incremental Cost-Effectiveness Ratio (ICER)
180 and 365 days
Full-Scale Trial Secondary Outcome: Post Thrombotic Syndrome
Time Frame: 365 days
VILLALTA scale score ≥5 signifies clinically meaningful Post Thrombotic Syndrome
365 days
Full-Scale Trial Secondary Outcome: Severe Post Thrombotic Syndrome
Time Frame: 180 and 365 days
VILLALTA scale score ≥ 15 signifies significant clinically meaningful Post Thrombotic Syndrome or presence of ulcer will be collected
180 and 365 days
Full-Scale Trial Secondary Outcome: Severity of Post Thrombotic Syndrome
Time Frame: 180 and 365 days
Continuous VILLALTA score (VILLALTA scale score ≥5 signifies clinically meaningful Post Thrombotic Syndrome)
180 and 365 days
Full-Scale Trial Secondary Outcome: Patient Reported VILLALTA Scale
Time Frame: 180 and 365 days
Full-Scale Trial Secondary Outcome: Patient Reported VILLALTA Scale (VILLALTA scale score ≥5 signifies clinically meaningful Post Thrombotic Syndrome)
180 and 365 days
Full-Scale Trial Secondary Outcome: Venous disease Specific Quality of Life
Time Frame: 180 and 365 days
Scoring using VEINES-QOL/Sym (The VEINES-QOL summary score (based on 25 items) estimates the impact of chronic venous disease upon QOL)
180 and 365 days
Full-Scale Trial Secondary Outcome: Health-Related Quality of Life
Time Frame: 180 and 365 days
Scoring using EuroQoL-EQ-5D-5L (EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state)
180 and 365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Hospital Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc Carrier, MD,MSc,FRCPC, Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CONQUER-DVT Pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

To be developed

IPD Sharing Time Frame

Upon completion of the full-scale trial

IPD Sharing Access Criteria

Contact Principal Investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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