Secondary Prevention of VTE in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis

Phase 4

Recruiting

• Conditions: Venous Thromboembolism; Cancer; Upper Extremity Deep Vein Thrombosis; Catheter-Related Infections
• Interventions: Drug: Apixaban

• Registration Number: NCT06603870
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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.

Study Timeline

• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-09-16
• Study First Posted: 2024-09-19
• Study Start: 2024-12-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06
• Primary Completion: 2029-10
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apixaban	Apixaban	2.5 mg twice daily

Primary Outcome Measures

Name	Time	Method
Venous Thromboembolism (VTE) Rate	6 months	The rates of symptomatic, objectively confirmed new or recurrent major VTE (proximal upper or lower extremity DVT, segmental or larger pulmonary embolism (PE)) with corresponding 95% Confidence Interval (CI) at 6 months.

Secondary Outcome Measures

Name	Time	Method
Major Venous Thromboembolism (VTE) and Major bleeding Rate	3 months	Rates of new/recurrent symptomatic major VTE and major bleeding at 3 months.
New/recurrent symptomatic catheter-related upper extremity Deep Vein Thrombosis (DVT).	3 months and 6 months	New/recurrent symptomatic catheter-related upper extremity DVT.
New incidental Venous Thromboembolism (VTE)	3 months and 6 months	New incidental VTE (PE or upper or lower extremity DVT), defined as VTE diagnosed on imaging studies obtained not for concern of VTE, such as cancer staging scans.
New Deep Vein Thrombosis (DVT)	3 months and 6 months	New/recurrent any distal upper or lower extremity DVT or subsegmental PE.
Superficial vein thrombosis of upper or lower extremities	3 months and 6 months	Superficial vein thrombosis of upper or lower extremities
New unusual site Venous Thromboembolism (VTE)	3 months and 6 months	New unusual site VTE (such as splanchnic vein, cerebral vein, or gonadal vein thrombosis).
Clinically Relevant Non-Major Bleeding (CRNMB) events	3 months and 6 months	CRNMB events by International Society on Thrombosis and Haemostasis (ISTH) criteria2 and composite major bleeding and CRNMB events.
Arterial thromboembolic events	3 months and 6 months	Arterial thromboembolic events (objectively confirmed), including myocardial infarction, stroke, peripheral arterial disease, or other systemic arterial embolism.
All-cause mortality	3 months and 6 months	All-cause mortality
Correlative biomarkers	6 months	Correlative biomarkers at 6 months, while the exact list of correlative biomarkers is to be determined at the time of study completion, examples include D-dimer, P-selectin, prothrombin F1+F2, thrombin generation, etc.
Health-related quality of life using the EuroQoL-5D-5L Questionnaire	6 months	Health-related quality of life using EuroQoL-5D-5L (5Dimension- mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5L- severity levels) questionnaires on enrollment and at 6 months. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state.

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada