- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07388056
Efficacy and Safety of Extended Anticoagulant Therapy in Cancer Associated Thrombosis in Thai Population
Efficacy and Safety of Extended Anticoagulant Therapy in Cancer Associated Thrombosis-A Ten Year Retrospective Study.
The goal of this observational study is to learn about the long-term efficacy and safety of extended anticoagulant treatment in patients with cancer associated thrombosis. (CAT) The main question it aims to answer is:
• Does extended prophylactic dose anticoagulant provide comparable efficacy and safety to therapeutic dosing after 6-month treatment of anticoagulant? The medical record data of participants who's already received for at least 6-month anticoagulant treatment upon regular medical care for CAT will be collected and analyzed about their recurrent thrombosis, anticoagulant related bleeding, and survival outcome.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adult patients aged ≥18 years with histopathological confirmed cancer, treated at Thammasat University Hospital and Panyananthaphikkhu Chonprathan Medical Center between January 2012 and December 2022, were eligible for inclusion.
Patients were initially screened using ICD-10 diagnostic codes C00-D009 for malignancy in conjunction with codes for venous thromboembolism (I82.-, other venous embolism and thrombosis; K55.0, mesenteric vein thrombosis; I82.0, hepatic vein thrombosis; K75.1, phlebitis of the portal vein; and I26.-, pulmonary embolism). Eligible patients required to have a radiologically confirmed diagnosis of cancer-associated thrombosis (CAT) and to have received anticoagulation therapy for at least six months. Clinical data were extracted from the Computerized Provider Order Entry (CPOE) system.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Here's a polished version of your Inclusion and Exclusion Criteria section with grammar, spelling, and phrasing corrected for clarity and formal research style:
Inclusion Criteria
- Adult patients aged ≥18 years
- Histopathologically confirmed cancer
- Radiologically confirmed diagnosis of cancer-associated thrombosis (CAT)
- Received anticoagulation therapy for at least six months Exclusion Criteria
- Patients who do not meet the inclusion criteria
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Therapeutic dose anticoagulant group
including patients with the standard therapeutic dose-administered after the initial six-month treatment period.
|
warfarin at therapeutic level (INR 2-3), Low molecular weight heparin (LMWH) DOAC
|
|
Prophylactic dose anticoagulant group
including patients with the doses lower than therapeutic dose-administered at any point after the initial six-month treatment period.
|
warfarin at therapeutic level (INR 2-3), Low molecular weight heparin (LMWH) DOAC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recurrent thrombosis
Time Frame: After completing 6-month of treatment to the time that anticoagulant stop or recurrent thrombosis occurred through study completion, at the end of December 2025.
|
cumulative incidence of recurrent thrombosis
|
After completing 6-month of treatment to the time that anticoagulant stop or recurrent thrombosis occurred through study completion, at the end of December 2025.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anticoagulant related bleeding
Time Frame: After completing 6-month of treatment to the time that anticoagulant stop or bleeding occurred through study completion, at the end of December 2025.
|
cumulative incidence of bleeding
|
After completing 6-month of treatment to the time that anticoagulant stop or bleeding occurred through study completion, at the end of December 2025.
|
|
Overall survival
Time Frame: The time from VTE diagnosis to last follow up or die through study completion, at the end of December 2025.
|
Overall survival
|
The time from VTE diagnosis to last follow up or die through study completion, at the end of December 2025.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTU-EC-IM-1-301/65
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
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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