Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 6:16 PM
Study NCT ID:
NCT04128956
Status:
TERMINATED
Last Update Posted:
2024-03-01
First Post:
2019-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aspirin® Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With PTS
Sponsor:
University of Zurich
Organization:
Study Overview
Official Title:
Aspirin® Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With Post-thrombotic Syndrome a Multi-center, International, Randomized, Open Label, Controlled Trial
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recommendation by DSMB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARIVA
Brief Summary:
To show if a combination therapy of rivaroxaban plus Aspirin® is more efficient (superiority testing) as rivaroxaban alone in the prevention of early venous stent thrombosis in patients suffering from post-thrombotic syndrome in the first 6 months following endovascular therapy To demonstrate tolerability of combination therapy of Aspirin® plus rivaroxaban in long-term treatment.
Detailed Description:
Deep vein thrombosis is associated with severe morbidity and mortality. It is the most frequent type of venous thromboembolism (VTE) and responsible for approximately 800.000 deaths per year in the European Union and the United States combined. The post-thrombotic syndrome (PTS) is a frequent long-term complication of proximal deep vein thrombosis (DVT), which occurs in up to 50% of patients despite adequate anticoagulation therapy and compression stockings. Patients with DVT of the inferior vena cava or iliac veins are at highest risk for the development of PTS. Inadequate recanalization and persistent venous outflow obstruction promotes the development of venous hypertension, secondary valve damage, valvular reflux, and the clinical manifestation of PTS, which consists of a similar set of signs and symptoms as in superficial venous insufficiency. Symptoms may include leg edema, pruritus, dysesthesia, leg pain on standing, skin changes, venous claudication with limited exercise capacity, and leg ulcers. Venous ulcers occur in approximately 10% of patients with iliofemoral DVT after 3 years.
The diagnosis of PTS is made based on the presence of its clinical features, a prior history of proximal DVT, and the results of imaging studies. Clinical scores, such as the Villalta score, can function as a tool to stage severity of disease. PTS in classified as mild if the Villalta score is 5-9, moderate if the Villalta score is 10-14, and severe if the Villata score exceeds 15 points. Disabling venous claudication can be diagnosed by treadmill exercise tests. Magnetic resonance imaging venography can be used in addition to duplex ultrasound to objectify central venous obstruction, and unmark underlying strategic compression sides (e.g. May-Thurner syndrome).
Recommendations by the American Heart Association for endovascular treatment of PTS suggest percutaneous recanalization including the implantation of stents for symptomatic patients) Endovascular therapy with provisional stent placement shows promising clinical outcomes to improve PTS-associated symptoms, including leg ulcers. However, there is significant risk for early stent thrombosis, estimated as high as 21% after 12 months.
Antithrombotic therapy is the corner stone of the prevention of stent thrombosis, but there is great inconsistency in the use of antithrombotic agents. The value of extended anticoagulation therapy in PTS patients beyond the durations recommended in VTE management guidelines is controversial, and it has not been specifically investigated in the presence of venous stent implants. Although oral anticoagulants are accepted as the main therapy regimen, the benefit of antiplatelet therapy (APT) in the early phase after venous stent implantation is unclear.
According to a recent international survey completed by 106 experts, one third reported to use life-long anticoagulation with a vitamin-K antagonist (VKA), and another 19% chose life-long anticoagulation with direct anticoagulant (DOAC) for a presented case scenario of a PTS patients treated with venous stents. The use of APT following stent placement alone or in combination with an anticoagulant was reported in 7% and 13%, respectively, whereas 25% reported use of APT following discontinuation of ACT.
Conventionally, antiplatelet agents, such as acetylsalicylic acid, are regarded as drugs that prevent arterial thrombosis, as platelet adhesion predominates clotting in high-flow, high-sheer circulation.
There is compelling evidence that Aspirin® is effective in the prevention of arterial stent thrombosis, but it is unclear, whether it can prevent venous stent thrombosis.
The diagnosis of PTS is made based on the presence of its clinical features, a prior history of proximal DVT, and the results of imaging studies. Clinical scores, such as the Villalta score, can function as a tool to stage severity of disease. PTS in classified as mild if the Villalta score is 5-9, moderate if the Villalta score is 10-14, and severe if the Villata score exceeds 15 points. Disabling venous claudication can be diagnosed by treadmill exercise tests. Magnetic resonance imaging venography can be used in addition to duplex ultrasound to objectify central venous obstruction, and unmark underlying strategic compression sides (e.g. May-Thurner syndrome).
Recommendations by the American Heart Association for endovascular treatment of PTS suggest percutaneous recanalization including the implantation of stents for symptomatic patients) Endovascular therapy with provisional stent placement shows promising clinical outcomes to improve PTS-associated symptoms, including leg ulcers. However, there is significant risk for early stent thrombosis, estimated as high as 21% after 12 months.
Antithrombotic therapy is the corner stone of the prevention of stent thrombosis, but there is great inconsistency in the use of antithrombotic agents. The value of extended anticoagulation therapy in PTS patients beyond the durations recommended in VTE management guidelines is controversial, and it has not been specifically investigated in the presence of venous stent implants. Although oral anticoagulants are accepted as the main therapy regimen, the benefit of antiplatelet therapy (APT) in the early phase after venous stent implantation is unclear.
According to a recent international survey completed by 106 experts, one third reported to use life-long anticoagulation with a vitamin-K antagonist (VKA), and another 19% chose life-long anticoagulation with direct anticoagulant (DOAC) for a presented case scenario of a PTS patients treated with venous stents. The use of APT following stent placement alone or in combination with an anticoagulant was reported in 7% and 13%, respectively, whereas 25% reported use of APT following discontinuation of ACT.
Conventionally, antiplatelet agents, such as acetylsalicylic acid, are regarded as drugs that prevent arterial thrombosis, as platelet adhesion predominates clotting in high-flow, high-sheer circulation.
There is compelling evidence that Aspirin® is effective in the prevention of arterial stent thrombosis, but it is unclear, whether it can prevent venous stent thrombosis.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-001723-12 | EUDRACT_NUMBER | None | View |