NCT06603870 Secondary Prevention of VTE in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis
| NCT ID | NCT06603870 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | Venous Thromboembolism |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2029-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 330 participants in total. It began in 2024-12-19 with a primary completion date of 2029-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Tzu-Fei Wang, MD, MPH
PRINCIPAL INVESTIGATOR
Ottawa Hospital Research Institute
Frequently Asked Questions
Who can join the NCT06603870 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Thromboembolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06603870 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06603870 currently recruiting?
Yes, NCT06603870 is actively recruiting participants. Contact the research team at tzwang@toh.ca for enrollment information.
Where is the NCT06603870 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT06603870 clinical trial?
NCT06603870 is sponsored by Ottawa Hospital Research Institute. The principal investigator is Tzu-Fei Wang, MD, MPH at Ottawa Hospital Research Institute. The trial plans to enroll 330 participants.