Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-28
Brief Title:
Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis The Conquer-DVT Pilot Trial
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis A Randomized Controlled Pilot Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose of the pilot trial
To assess the feasibility of a full-scale double-blind placebo-controlled randomized trial assessing whether low-dose colchicine 05 mg daily reduces the risk of post-thrombotic syndrome PTS in patients with proximal lower extremity deep vein thrombosis DVT
To assess the feasibility of a full-scale double-blind placebo-controlled randomized trial assessing whether low-dose colchicine 05 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 11 ratio to receive one tablet of colchicine 05 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None