Prevenzione secondaria del TEV nei pazienti con cancro e trombosi venosa profonda degli arti superiori correlata a catetere (STREAM-Line)
Prevenzione secondaria della tromboembolia venosa in pazienti affetti da cancro e trombosi venosa profonda degli arti superiori correlata a catetere (studio STREAM-Line)
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).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 4
Contatti e Sedi
Contatto studio
- Nome: Tzu-Fei Wang, MD, MPH
- Numero di telefono: 73755 6137379988
- Email: tzwang@toh.ca
Luoghi di studio
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L6
- Reclutamento
- The Ottawa Hospital
-
Contatto:
- Cecilia Germano
- Email: cegermano@ohri.ca
-
Sault Ste. Marie, Ontario, Canada
- Reclutamento
- Sault Area Hospital
-
Contatto:
- Natalie Walde
- Email: walden@sah.on.ca
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Venous Thromboembolism (VTE) Rate
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Major Venous Thromboembolism (VTE) and Major bleeding Rate
Lasso di tempo: 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).
Lasso di tempo: 3 months and 6 months
|
New/recurrent symptomatic catheter-related upper extremity DVT. |
3 months and 6 months
|
|
New incidental Venous Thromboembolism (VTE)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 3 months and 6 months
|
Superficial vein thrombosis of upper or lower extremities |
3 months and 6 months
|
|
New unusual site Venous Thromboembolism (VTE)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 3 months and 6 months
|
All-cause mortality |
3 months and 6 months
|
|
Correlative biomarkers
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Tzu-Fei Wang, MD, MPH, Ottawa Hospital Research Institute
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STREAM-Line
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