Venous ThromboembolismPhase 3NCT06440694
Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial)
A Phase 3 study testing Colchicine 0.5 mg po in people with Venous Thromboembolism, run by Ottawa Hospital Research Institute at 4 sites in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Colchicine 0.5 mg po
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 4 sitesCanada
- Study dates
- 7 Jul 2025to 1 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of an allergic reaction or significant sensitivity to colchicine.
- Requirement of colchicine for other indications.
- 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.
- Known or suspected, recent (<30 days) or active infections (acute or chronic).
- History of cirrhosis, chronic active hepatitis, or severe liver disease.
- Recent (<30 days) or chronic use of systemic (oral, intravenous) immunosuppressive drugs (including but not limited to steroids, tumor necrosis factor-alpha blockers, cyclosporine).
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- Known active cancer.
- 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.
- Pregnancy, breast feeding or may be considering pregnancy during the study period or women of childbearing potential unwilling to use appropriate contraception during sex;
- The use of medication with known drug-to-drug interactions (including but not limited to erythromycin or clarithromycin).
- Unable or unwilling to provide consent.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
Centre de recherche du Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
Amélie Martin, 514-890-8000 ext. 31541, amelie.martin.chum@ssss.gouv.qc.ca
Emmanuelle Duceppe, MD,PhD,FRCPC
- Not yet recruiting
The Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2
Stephanie Scala, 514-340-8222 ext. 22178, Stephanie.Scala@ladydavis.ca
Susan Kahn, MD,MSc,FRCPC
- Recruiting
The Ottawa Hospital General Campus
Ottawa, Ontario, K1H 8L6
Erica Brown, ericabrown@ohri.ca
Marc Carrier, MD,MSc,FRCPC
- Recruiting
Windsor Regional Hospital
Windsor, Ontario, N8W2X3
Vivian Alie, 519-253-3191 ext. 58642, Vivian.Alie@wrh.on.ca
Andrea Cervi, MD, MSc, FRCPC,
About this study
Official title: 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).
Read the 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).
- Conditions
- Venous Thromboembolism
- Being tested
- Colchicine 0.5 mg po, Placebo 0.5 mg po
- Keywords
- Proximal Lower Extremity Deep Vein Thrombosis, Randomized Trial, Colchicine, Post Thrombotic Syndrome, Inflammation
- Medical subject headings
- Venous Thromboembolism, Postthrombotic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 mg poDrug
Also called Myinfla tablet 0.5 mg po daily
Colchicine 0.5 mg po once daily for 180 days.
Placebo 0.5 mg poDrug
Also called Placebo 0.5 mg po daily
Placebo 0.5 mg po once daily for 180 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm: Colchicine | Experimental | 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. Receives: Drug: Colchicine 0.5 mg po |
| Control Arm : Placebo | Placebo comparator | 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. Receives: Drug: Placebo 0.5 mg po |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot Trial Primary Outcome: Recruitment Rate
Mean number of participants recruited per site per month
Measured: 12 months
Full-Scale Trial Primary Outcome: Post Thrombotic Syndrome
VILLALTA scale score ≥5 signifies clinically meaningful Post Thrombotic Syndrome
Measured: 180 days
Secondary outcomes (17)
Pilot Trial Secondary Outcome: Eligibility Rate
Proportion of screened patients who are eligible
Measured: 12 months
Pilot Trial Secondary Outcome: Consent Rate
Proportion of eligible patients who provide consent
Measured: 12 months
Pilot Trial Secondary Outcome: Retention Rate
Proportion of participants retained at follow-up
Measured: 12 months
Pilot Trial Secondary Outcome: Study Completion Rate
Proportion of participants who completed all study procedures
Measured: 12 months
Pilot Trial Secondary Outcome: Adherence Rate
Adherence to study drug measured by pill count at the end of follow-up
Measured: 12 months
Pilot Trial Secondary Outcome: Reasons for declining participation
Pilot Trial Secondary Outcome: Reasons for declining participation
Measured: 12 months
Full-Scale Trial Secondary Outcome: Post Thrombotic Syndrome
VILLALTA scale score ≥5 signifies clinically meaningful Post Thrombotic Syndrome
Measured: 365 days
Full-Scale Trial Secondary Outcome: Severe Post Thrombotic Syndrome
VILLALTA scale score ≥ 15 signifies significant clinically meaningful Post Thrombotic Syndrome or presence of ulcer will be collected
Measured: 180 and 365 days
Full-Scale Trial Secondary Outcome: Severity of Post Thrombotic Syndrome
Continuous VILLALTA score (VILLALTA scale score ≥5 signifies clinically meaningful Post Thrombotic Syndrome)
Measured: 180 and 365 days
Full-Scale Trial Secondary Outcome: Patient Reported VILLALTA Scale
Full-Scale Trial Secondary Outcome: Patient Reported VILLALTA Scale (VILLALTA scale score ≥5 signifies clinically meaningful Post Thrombotic Syndrome)
Measured: 180 and 365 days
Full-Scale Trial Secondary Outcome: Recurrent Venous Thromboembolism
Full-Scale Trial Secondary Outcome: Recurrent Venous Thromboembolism
Measured: 180 and 365 days
Full-Scale Trial Secondary Outcome: Major Bleeding
As per International Society on Thrombosis and Haemostasis (ISTH) definition
Measured: 180 and 365 days
Full-Scale Trial Secondary Outcome: Clinically Relevant Non-Major Bleeding
As per ISTH definition
Measured: 180 and 365 days
Full-Scale Trial Secondary Outcome: Overall Mortality
Full-Scale Trial Secondary Outcome: Overall Mortality
Measured: 180 and 365 days
Full-Scale Trial Secondary Outcome: Venous disease Specific Quality of Life
Scoring using VEINES-QOL/Sym (The VEINES-QOL summary score (based on 25 items) estimates the impact of chronic venous disease upon QOL)
Measured: 180 and 365 days
Full-Scale Trial Secondary Outcome: Health-Related Quality of Life
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)
Measured: 180 and 365 days
Full-Scale Trial Secondary Outcome: Incremental Cost-Effectiveness Ratio (ICER)
Full-Scale Trial Secondary Outcome: Incremental Cost-Effectiveness Ratio (ICER)
Measured: 180 and 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start7 Jul 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Pilot Trial comparing two groups - Colchicine 0.5 mg po once daily for 180 days vs Placebo 0.5 mg po once daily for 180 days.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Carrier, MD,MSc,FRCPC, Principal investigator, Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440694
- Sponsor's protocol ID
- CONQUER-DVT Pilot
- Status last verified
- Jul 2026
- First submitted
- 28 May 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To be developed
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT06440694
- Acronym / sponsor ID
- CONQUER-DVT Pilot
- Conditions
- Venous Thromboembolism
- Keywords
- Proximal Lower Extremity Deep Vein Thrombosis, Randomized Trial, Colchicine, Post Thrombotic Syndrome, Inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Pilot Trial comparing two groups - Colchicine 0.5 mg po once daily for 180 days vs Placebo 0.5 mg po once daily for 180 days.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm: Colchicine | Experimental | Drug: Colchicine 0.5 mg poColchicine 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. |
| Control Arm : Placebo | Placebo comparator | Drug: Placebo 0.5 mg poPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- History of an allergic reaction or significant sensitivity to colchicine.
- Requirement of colchicine for other indications.
- 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.
- Known or suspected, recent (<30 days) or active infections (acute or chronic).
- History of cirrhosis, chronic active hepatitis, or severe liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5 mg poAlso: Myinfla tablet 0.5 mg po dailyColchicine 0.5 mg po once daily for 180 days. | Drug | Experimental Arm: Colchicine |
| Placebo 0.5 mg poAlso: Placebo 0.5 mg po dailyPlacebo 0.5 mg po once daily for 180 days. | Drug | Control Arm : Placebo |
Primary outcome
Pilot Trial Primary Outcome: Recruitment Rate
Time frame: 12 months
Mean number of participants recruited per site per month
Full-Scale Trial Primary Outcome: Post Thrombotic Syndrome
Time frame: 180 days
VILLALTA scale score ≥5 signifies clinically meaningful Post Thrombotic Syndrome
17 secondary outcomes
Pilot Trial Secondary Outcome: Eligibility Rate
Time frame: 12 months
Pilot Trial Secondary Outcome: Consent Rate
Time frame: 12 months
Pilot Trial Secondary Outcome: Retention Rate
Time frame: 12 months
Pilot Trial Secondary Outcome: Study Completion Rate
Time frame: 12 months
Pilot Trial Secondary Outcome: Adherence Rate
Time frame: 12 months
Pilot Trial Secondary Outcome: Reasons for declining participation
Time frame: 12 months
Full-Scale Trial Secondary Outcome: Post Thrombotic Syndrome
Time frame: 365 days
Full-Scale Trial Secondary Outcome: Severe Post Thrombotic Syndrome
Time frame: 180 and 365 days
Full-Scale Trial Secondary Outcome: Severity of Post Thrombotic Syndrome
Time frame: 180 and 365 days
Full-Scale Trial Secondary Outcome: Patient Reported VILLALTA Scale
Time frame: 180 and 365 days
Full-Scale Trial Secondary Outcome: Recurrent Venous Thromboembolism
Time frame: 180 and 365 days
Full-Scale Trial Secondary Outcome: Major Bleeding
Time frame: 180 and 365 days
Full-Scale Trial Secondary Outcome: Clinically Relevant Non-Major Bleeding
Time frame: 180 and 365 days
Full-Scale Trial Secondary Outcome: Overall Mortality
Time frame: 180 and 365 days
Full-Scale Trial Secondary Outcome: Venous disease Specific Quality of Life
Time frame: 180 and 365 days
Full-Scale Trial Secondary Outcome: Health-Related Quality of Life
Time frame: 180 and 365 days
Full-Scale Trial Secondary Outcome: Incremental Cost-Effectiveness Ratio (ICER)
Time frame: 180 and 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Yes. To be developed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Carrier, MD,MSc,FRCPC principal investigator
Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine 0.5 mg po in people with Venous Thromboembolism, run by Ottawa Hospital Research Institute at 4 sites 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 1 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Carrier, MD,MSc,FRCPC (6137378899 ext. Ext. 73668, mcarrier@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pilot Trial Primary Outcome: Recruitment Rate (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2026.