Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome

In patients with Behçet's syndrome (BS), deep venous thrombosis (DVT) is thought to result from inflammation of the vessel wall rather than hyper coagulability.
Post Thrombotic Syndrome (PTS) is frequent especially with recurrent episodes of deep vein thrombosis and may result in leg ulcers that are very difficult to treat. Vascular involvement is a major cause of morbidity and mortality among BS patients. However, one of the most controversial issues regarding the management of BS is whether DVT should be treated with anticoagulants. Moreover, use of anticoagulants exposes patients to serious bleeding, especially in those who presents simultaneous arterial aneurysms. However, many physicians are still using anticoagulants. This is the first prospective, randomized study assessing benefits of corticosteroids associated with anticoagulant compared to that of corticosteroids alone in DVT in BS patients. It will validate or not the use of anticoagulants in those situations. It will allow a direct comparison of the safety profile of those two schemes of treatment.

开始日期2025-01-15

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

NCT06894576

/ RecruitingN/AIIT

Development of a Risk Stratification Score for Recurrent Venous Thromboembolism and Treatment-related Clinically Relevant Bleeding in Patients With Cancer-associated Thrombosis

The objective of this study is to prospectively develop a risk assessment model (RAM) that accurately identifies anticoagulated cancer-associated thrombosis (CAT) patients at low- and high-risk of recurrent venous thromboembolism (VTE) and clinically relevant bleeding within 6 months following the CAT diagnosis and to create a biobank of plasma and whole blood samples for further translational research in cancer genetics and hemostasis.

开始日期2024-12-03

申办/合作机构

Ottawa Hospital Research Institute

[+1]

ChiCTR2400085994

/ SuspendedN/AIIT

A randomized controlled study of pharmacists' intervention model for the management of antithrombotic drug compliance

开始日期2024-07-01

申办/合作机构

深圳市妇幼保健院

100 项与复发性深静脉血栓形成相关的临床结果

登录后查看更多信息

100 项与复发性深静脉血栓形成相关的转化医学

登录后查看更多信息

0 项与复发性深静脉血栓形成相关的专利（医药）

登录后查看更多信息

2,900

项与复发性深静脉血栓形成相关的文献（医药）

2025-05-01·Journal of Vascular Surgery: Venous and Lymphatic Disorders

A preliminary experience on the efficacy, safety, and short-term results in the treatment of acute bilateral iliofemoral deep vein thrombosis with the Angiojet rheolytic thrombectomy

Article

作者: Türkmen, Ufuk ; Yiğit, Görkem

OBJECTIVEThis study aimed to examine the early clinical outcomes of AngioJet rheolytic thrombectomy (RT) in patients with acute bilateral iliofemoral deep vein thrombosis (IFDVT), with a specific focus on the incidence of post-thrombotic syndrome.METHODSFrom March 2021 to August 2023, 16 consecutive patients with acute bilateral IFDVT treated with AngioJet RT at our center were evaluated. Primary outcomes include patency of the target veins, development of post-thrombotic syndrome, recurrent DVT, and procedure-related death. Secondary outcomes included minor or major bleeding, acute kidney injury, documented hemoglobinuria, cardiac event, pulmonary embolism, limb loss, and death.RESULTSThe mean age of the patients was 69 ± 12 years (range, 53-87 years). Malignancy and recent major surgery were the most prevalent risk factors, each observed in 25% of patients (n = 4). Technical success, complete clot removal, and alleviation of symptoms were achieved in all patients (n = 16; 100%). In one-quarter of the patients (n = 4), transient hemoglobinuria was observed following the procedure. This complication resolved spontaneously after adequate fluid replenishment. Minor bleeding occurred in three patients (19%), whereas no patients had major bleeding complication. There was one postoperative acute kidney injury and transient bradycardia (6%). Three patients died after the procedures (19%). One patient (6%) developed postoperative massive pulmonary embolism. The mean follow-up was 11 ± 6 months (range, 5-19 months). The primary patency rate was 92% and 91%, respectively, 6 and 12 months after procedures. One patient had reocclusion during the follow-up.CONCLUSIONSAngioJet RT applied to patients with bilateral IFDVT provides a promising picture, providing a patent vein lumen with high procedural success and achieving convincing early symptomatic improvement in severely symptomatic patients with impaired quality of life. In this early case series, the feasibility of the AngioJet device in elderly cases appears to be a significant problem. Therefore, patient selection is essential.

2025-05-01·Journal of Chromatography B

Development and validation of a stability-indicating reversed phase high-performance liquid chromatography method for quantifying rivaroxaban (XARELTO)

Article

作者: Mestareehi, Aktham

Rivaroxaban is an anticoagulant medication that targets a key stage in the blood clotting process, preventing the formation and growth of clots. It is commonly used to prevent thrombosis or inhibit the enlargement of existing clots. Rivaroxaban functions as a Factor Xa inhibitor and is indicated for: reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treating deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as reducing the risk of recurrent DVT and PE, and prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery. A robust, precise, and selective reversed-phase high-performance liquid chromatography (HPLC) method was developed and validated for analyzing Rivaroxaban in raw materials. Isocratic elution at a flow rate of 1 mL/min was performed using a Thermo ODS Hypersil C18 column (4.6 × 250 mm, 5 μm) at ambient temperature. The mobile phase consisted of monobasic potassium phosphate at pH 2.9 and acetonitrile in a 70:30 (v/v) ratio, with UV detection at 249 nm. Linearity was established in the concentration range of 50-1000 ppm (r² = 0.999), and the retention time for Rivaroxaban was approximately 12 min. The percentage relative standard deviation (RSD) for precision and accuracy was consistently below 2.0 %. Rivaroxaban was subjected to forced degradation under various conditions, including acid and base hydrolysis, hydrogen peroxide oxidation, heat, and UV light exposure. The developed method was validated for specificity, robustness, linearity, accuracy, precision, limit of detection (LOD), and limit of quantitation (LOQ), following International Conference on Harmonisation (ICH) guidelines. The LOD for impurities and degradants was found to be 0.3 ppm, with an LOQ of 1 ppm.

2025-04-10·New England Journal of Medicine

Extended Reduced-Dose Apixaban for Cancer-Associated Venous Thromboembolism

Article

作者: Grange, Claire ; Bamias, Aristotelis ; Klok, Frederikus A. ; Le Gal, Grégoire ; Huisman, Menno V. ; Verhamme, Peter ; Agnelli, Giancarlo ; Ay, Cihan ; Mahé, Isabelle ; Monreal, Manuel ; Chidiac, Jean ; Yeo, Erik ; Szmit, Sebastian ; Otero-Candelera, Remedios ; Meyer, Guy ; Torbicki, Adam ; Girard, Philippe ; Mismetti, Patrick ; Couturaud, Francis ; Robert-Ebadi, Helia ; Laporte, Silvy ; Chapelle, Céline ; Sanchez, Olivier ; López-Núñez, Juan J. ; Westerweel, Peter ; Righini, Marc ; Mayeur, Didier ; Vicaut, Eric ; Becattini, Cecilia ; Cohen, Alexander T. ; Maraveyas, Anthony ; Syrigos, Kostas ; Falvo, Nicolas ; Bertoletti, Laurent ; Carrier, Marc

BACKGROUNDIn patients with active cancer and venous thromboembolism, whether extended treatment with a reduced dose of an oral anticoagulant is effective in preventing recurrent thromboembolic events and decreasing bleeding is unclear.METHODSWe conducted a randomized, double-blind, noninferiority trial with blinded central outcome adjudication. Consecutive patients with active cancer and proximal deep-vein thrombosis or pulmonary embolism who had completed at least 6 months of anticoagulant therapy were randomly assigned in a 1:1 ratio to receive oral apixaban at a reduced (2.5 mg) or full (5.0 mg) dose twice daily for 12 months. The primary outcome was centrally adjudicated fatal or nonfatal recurrent venous thromboembolism, assessed in a noninferiority analysis (margin of 2.00 for the upper boundary of the 95% confidence interval of the subhazard ratio). The key secondary outcome was clinically relevant bleeding, assessed in a superiority analysis.RESULTSA total of 1766 patients underwent randomization at a median time since the index event of 8.0 months (interquartile range, 6.5 to 12.6); 866 patients were assigned to the reduced-dose group, and 900 to the full-dose group. The median treatment duration was 11.8 months (interquartile range, 8.3 to 12.1). Recurrent venous thromboembolism occurred in 18 patients (cumulative incidence, 2.1%) in the reduced-dose group and in 24 (cumulative incidence, 2.8%) in the full-dose group (adjusted subhazard ratio, 0.76; 95% confidence interval [CI], 0.41 to 1.41; P = 0.001 for noninferiority). Clinically relevant bleeding occurred in 102 patients (cumulative incidence, 12.1%) in the reduced-dose group and in 136 (cumulative incidence, 15.6%) in the full-dose group (adjusted subhazard ratio, 0.75; 95% CI, 0.58 to 0.97; P = 0.03). Mortality was 17.7% in the reduced-dose group and 19.6% in the full-dose group (adjusted hazard ratio, 0.96; 95% CI, 0.86 to 1.06).CONCLUSIONSExtended anticoagulation with reduced-dose apixaban was noninferior to full-dose apixaban for the prevention of recurrent venous thromboembolism in patients with active cancer. The reduced dose led to a lower incidence of clinically relevant bleeding complications than the full dose. (Funded by the Bristol-Myers Squibb-Pfizer Alliance; API-CAT ClinicalTrials.gov number, NCT03692065.).

项与复发性深静脉血栓形成相关的新闻（医药）

2025-01-21

·PRNewswire

TAHO Pharmaceuticals Completes Pivotal Trial of TAH3311, the First Oral Dissolving Film Anticoagulant

TAIPEI, Jan. 21, 2025 /PRNewswire/ -- TAHO Pharmaceuticals is pleased to announce the successful completion of the pivotal trial for TAH3311, the first anticoagulant oral dissolving film (ODF). This trial was conducted following detailed discussions and alignment with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), marking a major milestone in the advancement of this innovative product under the 505(b)(2) regulatory pathway. The trial enrolled 60 healthy volunteers to compare TAH3311 ODF with the Apixaban tablet (brand name Eliquis®) under the bioequivalence (BE) regulatory framework. Apixaban, a Factor Xa inhibitor, is widely used for stroke prevention and treatment of thromboembolic conditions due to its lower dosage requirements and reduced gastrointestinal bleeding risk compared to other anticoagulants. TAH3311 addresses a significant unmet need in this market by offering the first ODF formulation, providing a water-free alternative that is especially beneficial for patients with swallowing difficulties, including the elderly, stroke survivors, and children. According to IQVIA, the global market for anticoagulants is rapidly expanding, with apixaban achieving U.S. sales of $22.1 billion in 2023, making it the leading small-molecule drug globally and the second best-selling drug overall.* This remarkable growth highlights a significant opportunity for TAH3311 to address existing clinical unmet needs while offering a unique differentiation in an increasingly competitive landscape. With the trial's completion, TAHO Pharmaceuticals plans to prepare regulatory submissions in both the United States and Europe. Simultaneously, the company is actively pursuing strategic collaborations with international partners to accelerate the global launch of TAH3311 and maximize its impact in key markets. "The completion of this pivotal study is a significant step forward in TAHO's mission to bring innovative Transepithelial Delivery System (TDS) drug delivery solutions to patients worldwide," said Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals. "As the first ODF formulation in the anticoagulant space, TAH3311 has the potential to transform how these life-saving therapies are delivered, especially for patients who face difficulties with traditional tablet forms." *Source: About Apixaban Apixaban (co-developed by BMS and Pfizer under the brand name Eliquis®) is a direct factor Xa inhibitor and has been approved for clinical use in several thromboembolic disorders, including reduction of stroke risk in non-valvular atrial fibrillation, thromboprophylaxis following hip or knee replacement surgery, the treatment of deep vein thrombosis or pulmonary embolism, and prevention of recurrent deep vein thrombosis and pulmonary embolism. With notable safety advantages, it is the leading novel oral anticoagulant (NOAC). According to various industry reports, apixaban was the second-highest-selling drug globally in 2023. About TAHO Pharmaceuticals Ltd. Founded in 2010, TAHO Pharmaceuticals Ltd. leverages its proprietary Transepithelial Delivery System (TDS) to overcome the limitations of existing drugs and develop innovative dosage forms for niche markets. The TDS platform combines advanced transdermal and transmucosal delivery technologies, enabling the development of unique dosage forms such as transdermal patches, ODF, and buccal films. TAHO's diverse product portfolio spans a variety of therapeutic areas, including antithrombotic agents, opioid overdose antidotes, addiction treatments, pediatric ADHD, and chemotherapy-induced antiemetics. Among its notable achievements, TAH4411, an ODF for chemotherapy-induced nausea and vomiting, became the first product of its kind to receive regulatory approval and be commercialized in Japan. SOURCE Taho Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准

2024-12-06

·drugs

ASH: Reduced-Dose Anticoagulants Not Noninferior for Recurrent VTE

FRIDAY, Dec. 6, 2024 -- Noninferiority of reduced- versus full-dose anticoagulants cannot be proven in patients with venous thromboembolism who need extended anticoagulation, according to a study to be presented at the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego. Francis Couturaud, M.D., Ph.D., from the University of Brest in France, and colleagues conducted a multicenter, prospective, randomized trial comparing extended anticoagulation with reduced-dose versus full-dose direct oral anticoagulants in patients with venous thromboembolism at high risk for recurrence, who were initially treated for six to 24 months. The researchers found that recurrent venous thromboembolism occurred in 19 of 1,383 patients in the reduced-dose group versus 15 of 1,385 in the full-dose group during the 36-month median follow-up (five-year cumulative incidence, 2.2 versus 1.8 percent; hazard ratio, 1.32; 95 percent confidence interval, 0.67 to 2.60; P = 0.23 for noninferiority). Clinically relevant bleeding occurred in 96 patients in the reduced-dose group and 154 in the full-dose group (five-year cumulative incidence, 9.9 versus 15.2 percent). The composite outcome of recurrent venous thromboembolism and clinically relevant bleeding occurred in 113 and 166 patients in the reduced- and full-dose groups, respectively (five-year cumulative incidence, 11.8 versus 16.5 percent). All-cause death occurred in 4.3 and 6.1 percent of patients in the reduced- and full-dose groups, respectively. "The noninferiority of a reduced-dose versus a full-dose of direct anticoagulants to prevent recurrent venous thromboembolism could not be proven," the authors write. Several authors disclosed ties to the pharmaceutical industry. Abstract More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果ASH会议

2024-11-19

·PRNewswire

TAHO Pharmaceuticals Initiates U.S. Phase III Clinical Trial of TAH3311 Antithrombotic Oral Dissolving Film, Dosing First Subjects

TAIPEI, Nov. 19, 2024 /PRNewswire/ -- TAHO Pharmaceuticals Ltd. announced the dosing of the first subjects in its U.S. Phase III clinical trial for its lead product, TAH3311, an innovative antithrombotic oral dissolving film (ODF). In July 2023, the U.S. Food & Drug Administration (FDA) accepted TAHO's proposal for a 505(b)(2) NDA submission, based on a single pivotal bioequivalence study comparing the plasma concentration of TAH3311 to the approved tablet formulation. This pivotal, open-label, randomized, crossover trial will enroll 60 subjects. TAH3311 introduces a groundbreaking ODF formulation of apixaban, a widely recognized first-line treatment and gold standard for stroke prevention and thrombosis management. Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals, stated: "Our team at TAHO Pharmaceuticals is dedicated to developing 505(b)(2) new drug formulations to address the clinical disadvantages of existing medications. Apixaban, available exclusively in tablet form, often presents challenges for elderly patients, children, and stroke survivors who have difficulty swallowing. These patients frequently need to crush tablets, mix them with water, and administer them twice daily—a time-consuming and imprecise process that risks dosage loss. TAH3311 overcomes these barriers with a quick-dissolving oral film that melts on the tongue, requires no water, reduces the risk of choking, enhances patient adherence, and alleviates caregiver burden." By addressing the clinical limitations of the tablet form and leveraging the significant market potential of apixaban, TAHO Pharmaceuticals is advancing TAH3311 as a meaningful innovation in anticoagulant therapy. About Apixaban Apixaban (co-developed by BMS and Pfizer under the brand name Eliquis®) is a direct factor Xa inhibitor and has been approved for clinical use in several thromboembolic disorders, including reduction of stroke risk in non-valvular atrial fibrillation, thromboprophylaxis following hip or knee replacement surgery, the treatment of deep vein thrombosis or pulmonary embolism, and prevention of recurrent deep vein thrombosis and pulmonary embolism. With notable safety advantages, it is the leading novel oral anticoagulant (NOAC). According to various industry reports, apixaban was the second-highest-selling drug globally in 2023. About TAHO Pharmaceuticals Ltd. Founded in 2010, TAHO Pharmaceuticals Ltd. leverages its proprietary Transepithelial Delivery System (TDS) to overcome the limitations of existing drugs and develop innovative dosage forms for niche markets. The TDS platform combines advanced transdermal and transmucosal delivery technologies, enabling the development of unique dosage forms such as transdermal patches, ODF, and buccal films. TAHO's diverse product portfolio spans a variety of therapeutic areas, including antithrombotic agents, opioid overdose antidotes, addiction treatments, pediatric ADHD, and chemotherapy-induced antiemetics. Among its notable achievements, TAH4411, an ODF for chemotherapy-induced nausea and vomiting, became the first product of its kind to receive regulatory approval and be commercialized in Japan. Media Contact: TAHO Pharmaceuticals +886-2-2659-8515 [email protected] SOURCE Taho Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED