Secundaire preventie van VTE bij patiënten met kanker en kathetergerelateerde diepe veneuze trombose van de bovenste ledematen (STREAM-Line)
Secundaire preventie van veneuze trombo-embolie bij patiënten met kanker en kathetergerelateerde diepveneuze trombose van de bovenste ledematen (STREAM-Line-onderzoek)
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).
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 4
Contacten en locaties
Studiecontact
- Naam: Tzu-Fei Wang, MD, MPH
- Telefoonnummer: 73755 6137379988
- E-mail: tzwang@toh.ca
Studie Locaties
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L6
- Werving
- The Ottawa Hospital
-
Contact:
- Cecilia Germano
- E-mail: cegermano@ohri.ca
-
Sault Ste. Marie, Ontario, Canada
- Werving
- Sault Area Hospital
-
Contact:
- Natalie Walde
- E-mail: walden@sah.on.ca
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
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.
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.
Able and willing to provide informed consent.
Exclusion Criteria:
Active bleeding or other reasons for which anticoagulation is contraindicated.
Other indications requiring ongoing therapeutic dose of anticoagulation as deemed necessary by treating physicians (such as atrial fibrillation, mechanical heart valve, etc.).
Anticoagulation has been permanently stopped or reduced to prophylactic dose for > 5 days prior to enrollment for any reasons.
Pregnancy or breast feeding in patients who are prescribed a direct oral anticoagulant.
Concomitant use of strong inhibitors or inducers of both cytochrome P450 3A4 and P-glycoprotein in patients who are prescribed a direct oral anticoagulant.
Cancer is in remission and CVC is removed prior to enrollment.
Requirement of dual antiplatelet therapies.
Platelet count < 50 x 109/L or creatinine clearance < 30 ml/min.
Life expectancy of less than 3 months.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Apixaban
2.5 mg twice daily |
Patients will be enrolled after at least 3 months of therapeutic anticoagulation for an acute catheter-related upper extremity DVT while they are treated with therapeutic anticoagulation as standard of care. After enrollment, patients will be managed with prophylactic dose of anticoagulation as long as either a CVC or active cancer is present. If cancer goes into remission, at the time of CVC removal, anticoagulation will be stopped, but patients will continue to be followed until the end of the study at 6 months.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Venous Thromboembolism (VTE) Rate
Tijdsspanne: 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. |
6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Major Venous Thromboembolism (VTE) and Major bleeding Rate
Tijdsspanne: 3 months
|
Rates of new/recurrent symptomatic major VTE and major bleeding at 3 months. |
3 months
|
|
New/recurrent symptomatic catheter-related upper extremity Deep Vein Thrombosis (DVT).
Tijdsspanne: 3 months and 6 months
|
New/recurrent symptomatic catheter-related upper extremity DVT. |
3 months and 6 months
|
|
New incidental Venous Thromboembolism (VTE)
Tijdsspanne: 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. |
3 months and 6 months
|
|
New Deep Vein Thrombosis (DVT)
Tijdsspanne: 3 months and 6 months
|
New/recurrent any distal upper or lower extremity DVT or subsegmental PE. |
3 months and 6 months
|
|
Superficial vein thrombosis of upper or lower extremities
Tijdsspanne: 3 months and 6 months
|
Superficial vein thrombosis of upper or lower extremities |
3 months and 6 months
|
|
New unusual site Venous Thromboembolism (VTE)
Tijdsspanne: 3 months and 6 months
|
New unusual site VTE (such as splanchnic vein, cerebral vein, or gonadal vein thrombosis). |
3 months and 6 months
|
|
Clinically Relevant Non-Major Bleeding (CRNMB) events
Tijdsspanne: 3 months and 6 months
|
CRNMB events by International Society on Thrombosis and Haemostasis (ISTH) criteria2 and composite major bleeding and CRNMB events. |
3 months and 6 months
|
|
Arterial thromboembolic events
Tijdsspanne: 3 months and 6 months
|
Arterial thromboembolic events (objectively confirmed), including myocardial infarction, stroke, peripheral arterial disease, or other systemic arterial embolism. |
3 months and 6 months
|
|
All-cause mortality
Tijdsspanne: 3 months and 6 months
|
All-cause mortality |
3 months and 6 months
|
|
Correlative biomarkers
Tijdsspanne: 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. |
6 months
|
|
Health-related quality of life using the EuroQoL-5D-5L Questionnaire
Tijdsspanne: 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. |
6 months
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Tzu-Fei Wang, MD, MPH, Ottawa Hospital Research Institute
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STREAM-Line
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .