Clinical trial NCT06603870: Secondary Prevention of VTE in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis
Official title: Secondary Prevention of Venous Thromboembolism in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis (STREAM-Line Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Venous Thromboembolism
Cancer
Upper Extremity Deep Vein Thrombosis
Catheter-Related Infections
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Apixaban 2.5 mg twice daily
Primary purpose: TREATMENT

Brief summary: This trial seeks to evaluate a management strategy after the acute treatment duration (≥ 3 months of 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 acute treatment duration (≥ 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.

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 (including LMWH dose reduction to 75% after the first month) 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 ongoing therapeutic dose of anticoagulation as deemed necessary by treating physicians (such as atrial fibrillation, mechanical heart valve, etc.).
3. Anticoagulation has been permanently stopped or reduced to prophylactic dose prior to enrollment for any reasons, except for participants who were transitioned to apixaban dosing regimen consistent with the protocol (2.5 mg twice daily) for ≤ 3 days .
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.

Primary outcomes:
measure: Venous Thromboembolism (VTE) Rate
timeFrame: 6 months
Secondary outcomes:
measure: Major Venous Thromboembolism (VTE) and Major bleeding Rate
timeFrame: 3 months
measure: New/recurrent symptomatic catheter-related upper extremity Deep Vein Thrombosis (DVT).
timeFrame: 3 months and 6 months
measure: New incidental Venous Thromboembolism (VTE)
timeFrame: 3 months and 6 months
measure: New Deep Vein Thrombosis (DVT)
timeFrame: 3 months and 6 months
measure: Superficial vein thrombosis of upper or lower extremities
timeFrame: 3 months and 6 months
measure: New unusual site Venous Thromboembolism (VTE)
timeFrame: 3 months and 6 months
measure: Clinically Relevant Non-Major Bleeding (CRNMB) events
timeFrame: 3 months and 6 months
measure: Arterial thromboembolic events
timeFrame: 3 months and 6 months
measure: All-cause mortality
timeFrame: 3 months and 6 months
measure: Correlative biomarkers
timeFrame: 6 months
measure: Health-related quality of life using the EuroQoL-5D-5L Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Tzu-Fei Wang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: