2023-508147-43-00招募中4 期
Avoiding Risks of Thrombosis and bleeding in Surgery (ARTS): an international randomised controlled trial evaluating apixaban versus no anticoagulation in patients undergoing general abdominal, gynecologic and urologic surgery
HUS Helsinki University Hospital9 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年4月10日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 9
- 主要终点
- Incidence composite outcome of venous thromboembolism (VTE), defined as symptomatic deep vein thrombosis (DVT), or symptomatic non-fatal or fatal pulmonary embolism (PE) (at 90 days)
研究概览
简要总结
To evaluate the benefits and risks of thromboprophylaxis with apixaban (oral factor Xa inhibitor) DOAC therapy (with standard of care mechanical thromboprophylaxis) compared with no anticoagulant (with standard of care mechanical thromboprophylaxis) for patients undergoing urologic, gynecologic, and general abdominal surgery procedures, where patients are at sufficiently similar (and not high) risks of VTE and bleeding such that the net impact of pharmacological thromboprophylaxis remains uncertain
研究设计
- 分配方式
- Randomized
- 主要目的
- Avoiding Risks of Thrombosis and bleeding in Surgery (ARTS) trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Adult patients (≥18 years) at screening
- •Undergoing abdominal or pelvic surgery at similar (and not high) risk of VTE and bleeding
排除标准
- •Inability to provide informed consent
- •Platelet count <100 × 109/L (that is, 100 000 mg/L)
- •Hb <90 g/L (that is, <9 g/dL)
- •ALT >2 times upper limit of normal
- •Known allergy to apixaban
- •Taking strong inhibitors or inductors of both CYP 3A4 and P-glycoprotein, such as anti-seizure medications (e.g. phenytoin, fosphenytoin, carbamazepine), azole-antimycotics (e.g. ketoconazole, itraconazole), HIV-protease inhibitors (e.g. ritonavir, indinavir) and rifampicin
- •Concomitant procedures with high risk of VTE/bleeding
- •Previous VTE
- •Pregnant or breast-feeding female patients
- •Female participants who have had periods in the last 12 months and who are not using highly reliable contraception: (i) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); ii) progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); iii) intrauterine device (IUD); iv) intrauterine hormone-releasing system (IUS); v) bilateral tubal occlusion; vi) vasectomized partner; and vii) sexual abstinence from heterosexual intercourse during the entire period of risk associated with the study treatments
- •Previous randomization in this trial
- •Patient with active bleeding/hemorrhage during the last 6 months if not expected to be treated by surgery planned
- •Any reason why, in the opinion of the investigator(s), the patient should not participate
- •Lesion or condition if considered a significant risk factor for major bleeding a) This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
- •Anticoagulant treatment, antiplatelet treatment or omega-3 dietary supplement during previous 7 days preceding surgery and/or requiring within 30 days post-surgery
- •Patient who had during previous 6 months or are expected require within 30 days post-surgery chemotherapy/ radiation or hormone therapy for cancer
- •Known thrombophilia
- •Known bleeding disorder
- •Substantial liver impairment (for instance INR 1.4 or more during last 60 days)
- •eGRF <30 mL/min/1.73 m2
结局指标
主要结局
Incidence composite outcome of venous thromboembolism (VTE), defined as symptomatic deep vein thrombosis (DVT), or symptomatic non-fatal or fatal pulmonary embolism (PE) (at 90 days)
Incidence composite outcome of venous thromboembolism (VTE), defined as symptomatic deep vein thrombosis (DVT), or symptomatic non-fatal or fatal pulmonary embolism (PE) (at 90 days)
次要结局
- Incidence of symptomatic DVT (at 90 days)
- Incidence of symptomatic non-fatal or fatal PE (at 90 days)
- Safety outcome 1. Incidence of composite endpoint for major bleeding, defined as bleeding leading to a postoperative hemoglobin <70 g/L, transfusion of ≥1 unit of red blood cells, or bleeding that was judged to be the immediate cause of death (at 90 days)
- Safety outcome 2. Incidence of bleeding requiring re-intervention or endovascular embolization to stop bleeding (at 90 days)
- Other/Tertiary Outcome 1. Incidence of composite outcome of VTE, defined as symptomatic DVT, or symptomatic non-fatal or fatal PE (at 30 days)
- Other/Tertiary Outcome 2. Incidence of composite endpoint for major bleeding, defined as bleeding leading to a postoperative hemoglobin <70 g/L, transfusion of ≥1 unit of red blood cells, or bleeding that was judged to be the immediate cause of death (at 30 days)
- Other/Tertiary Outcome 3. Incidence of bleeding requiring re-intervention or endovascular embolization to stop bleeding (at 30 days)
- Other/Tertiary Outcome 4. Incidence of symptomatic non-fatal PE (at 90 days)
- Other/Tertiary Outcome 5. Incidence of symptomatic fatal PE (at 90 days)
- Other/Tertiary Outcome 6. Incidence of bleeding leading to a postoperative hemoglobin <70 g/L (at 90 days)
- Other/Tertiary Outcome 7. Incidence of transfusion of ≥1 unit of red blood cells (at 90 days)
- Other/Tertiary Outcome 8. Incidence of bleeding that was judged to be the immediate cause of death (at 90 days)
- Other/Tertiary Outcome 9. Incidence of bleeding requiring re-intervention to stop bleeding (at 90 days)
- Other/Tertiary Outcome 10. Incidence of bleeding requiring endovascular embolization to stop bleeding (at 90 days)
- Other/Tertiary Outcome 11. Overall mortality (at 90 days)
- Other/Tertiary Outcome 12. Suspected unexpected serious adverse reactions (SUSARs) potentially related to the study drug (apixaban) (at 90 days)
- Other/Tertiary Outcome 13. Serious Adverse Events (SAEs), any (at 90 days) • Any potentially drug-related SAEs, cardiac complications (serious), cerebral complications (serious), infectious complications (serious), admittance to intensive care, reoperation or other intervention for other reason than bleeding and other complication, details available at the CRF
- Other/Tertiary Outcome 14. Critical organ bleeding (at 90 days) • Intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intra-articular, and/or intramuscular bleeding with compartment syndrome
- Other/Tertiary Outcome 15. Cost-effectiveness of DOAC administration (at 90 days)
研究者
Vatsakeskus/ ARTS Project office
Scientific
HUS Helsinki University Hospital
研究点 (9)
Loading locations...
相似试验
招募中
不适用
Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic MalignanciesLymphomaLeukemiaNCT07270263Medical University of Gdansk100
招募中
2 期
Platelet inhibition versus direct oral anticoagulation in patients undergoing percutaneous closure of patent foramen ovale or atrial septal defect2024-517115-70-00Sint Antonius Ziekenhuis Stichting52
招募中
3 期
Antiplatelet therapy added to standard thromboprophylaxis to prevent thrombosis in pancreatic cancer patients - a randomized clinical trial (The PANART trial)2023-509022-22-00Akershus University Hospital744
招募中
4 期
EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation2024-518508-31-00Hamilton Health Sciences Corporation, PHRI Population Health Research Institute International380
招募中
4 期
SHORT RUN AF "Rivaroxaban versus standard of care for patients with excessive atrial ectopy or short atrial runs and high embolism risk"2024-516374-29-00Assistance Publique Hopitaux De Paris550