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Trial Title:
Secondary Prevention of VTE in Patients with Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis
NCT ID:
NCT06603870
Condition:
Venous Thromboembolism
Cancer
Upper Extremity Deep Vein Thrombosis
Catheter-Related Infections
Conditions: Official terms:
Catheter-Related Infections
Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Upper Extremity Deep Vein Thrombosis
Apixaban
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Apixaban 2.5 mg twice daily
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Apixaban
Description:
Apixaban is Health Canada approved for routine treatment and secondary prevention of VTE.
Upon enrollment and during follow-up, patients will be managed with a prophylactic dose
of apixaban (2.5 mg orally twice daily) as long as either a CVC or active cancer is
present. Apixaban will be stopped at the time of CVC removal and when cancer is in
remission. Patients will be instructed to contact the study team when their CVC is
removed (to determine if apixaban should be continued, based on cancer status at the
time), or any thrombotic or bleeding concerns were to occur in between visits. The
investigators will record loss to follow-up, drop out, or death during the study.
Arm group label:
Apixaban
Summary:
This trial seeks to evaluate a management strategy after the initial 3 months of standard
therapeutic anticoagulation for patients with cancer and catheter-related upper extremity
deep vein thrombosis (DVT).
Detailed description:
The aim of the STREAM-Line Trial is to demonstrate that the STREAM-Line management
strategy is safe after the initial 3 months of therapeutic anticoagulation in patients
with cancer and catheter-related upper extremity DVT. Upon enrollment and during
follow-up, patients will be managed with a prophylactic dose of apixaban (2.5 mg orally
twice daily) as long as either a central venous catheter (CVC) or active cancer is
present (STREAM-Line management strategy). Apixaban will be stopped at the time of CVC
removal and when cancer is in remission. Day 90±14 and Day 180+14 follow-up visit
procedures will be done by phone call or in person.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Adult patients (≥ 18 years old) with active cancer, defined as cancer (other than
localized non-melanoma skin cancer) diagnosed or treated within 6 months, or the
presence of metastatic, recurrent, or progressive malignancy, ongoing anticancer
therapy, or hematological malignancy not in complete remission.
2. Objectively confirmed catheter-related upper extremity DVT and treated with any
standard therapeutic anticoagulation for at least 3 months.
3. Able and willing to provide informed consent.
Exclusion Criteria:
1. Active bleeding or other reasons for which anticoagulation is contraindicated.
2. Other indications requiring a therapeutic dose of anticoagulation beyond 3 months
(such as atrial fibrillation, mechanical heart valve, etc.).
3. Not on therapeutic anticoagulation at the time of enrollment (patients whose
anticoagulation has been stopped or dose reduced prior to enrollment for any reasons
are excluded).
4. Known contraindication for apixaban, such as allergy, hypersensitivity, or
pregnancy.
5. Concomitant use of strong inhibitors or inducers of both cytochrome P450 3A4
(enzyme) and P-glycoprotein.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Ottawa Hospital
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Contact:
Last name:
Nana Frimpong
Phone:
+16137378899
Phone ext:
73958
Email:
nfrimpong@ohri.ca
Start date:
October 2024
Completion date:
October 2029
Lead sponsor:
Agency:
Ottawa Hospital Research Institute
Agency class:
Other
Source:
Ottawa Hospital Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06603870
