EUCTR2019-000610-10-IT进行中（未招募）1 期
Effects of low-dose Rivaroxaban combined with low-dose Aspirin versus low-dose aspirin alone on in vivo platelet Activation, endothelial function and inflammation in type 2 diabetic patients with stable peripheral or carotid artery disease: a randomized, crossover study - RivAsA
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 78 人开始时间: 2021年6月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria
- •- T2DM under glucose-lowering treatment;
- •- PAD defined as having one of the following;18
- •i) previous aorto-femoral bypass surgery, limb bypass surgery, percutaneous transluminal angioplasty revascularization of the iliac, or infrainguinal arteries;
- •ii) limb or foot amputation for arterial vascular disease;
- •iii) intermittent claudication and one or more of either an ankle brachial index (ABI) of less than 0.90 or a peripheral artery stenosis (=50%) documented by angiography or duplex ultrasound;
- •iv) carotid revascularization or asymptomatic carotid artery stenosis of at least 50% diagnosed by duplex ultrasound or angiography.
- •Patients with coronary artery disease and ABI <0.90 are also eligible. The ABI is calculated as the ratio of the highest limb systolic blood pressure over the highest brachial systolic blood pressure and Doppler measurements are not required.
- •- low-dose aspirin since at least 3 months; patients switching from clopidogrel to aspirin need to be on aspirin since at least 4 weeks;
- •- normal kidney and liver function as defined by creatinine clearance =45 ml/min with the Cockroft-Gault formula [Creatinine Clearance = {((l 40–age) x weight)/(72xSerum Creatinine)}x 0.85 (if female))] and AST and ALT<40 IU/L, according to the normal range of our Centralized Laboratory.
- •- CAD defined as one of the following:
- •Myocardial infarction within the last 20 years, or
- •Multi-vessel coronary disease with symptoms or with history of stable or unstable
- •angina, that is stenosis of =50% in 2 or more coronary arteries, confirmed by invasive coronary angiography, or non-invasive imaging or stress studies (e.g. exercise or
- •pharmacologic) suggestive of significant ischemia in 2 or more coronary territories; or in 1 coronary territory if at least one other territory has been revascularized.
- •Multi-vessel percutaneous coronary intervention (PCI), or
- •Multi-vessel CABG surgery
- •- Men and women between 50 and 80 years old
- •- Women will be recruited only if in a post-menopausal state defined as absence of menses for 12 consecutive months without an alternative medical cause
- •- Subjects able to understand and sign the informed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •-Type 1 diabetes mellitus
- •-Insulin therapy
- •-Concomitant treatment with antiplatelet drugs other than aspirin
- •-Ongoing cilostazol treatment
- •-Co-administration of strong CYP3A4 and P-gp inducers or inhibitors: voriconazole, ketoconazole, itraconazole, posaconazole, anti-HIV drugs such as ritonavir
- •-Concomitant treatment with any other anticoagulants, e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban, etc.)
- •-Concomitant treatment with any selective serotonin reuptake inhibitor (SSRI) or Serotonin And Noradrenaline Reuptake Inhibitor (SNRI), immunomodulators (ciclosporine, tacrolimus), anti-gout (probenecid); disease-modifier drugs for rheumatoid arthritis (i.e. methotrexate)
- •-Chronic use of steroids (prednisone >5 mg/die or equivalent)
- •-Chronic need for nonsteroidal anti-inflammatory drugs (NSAIDs), defined as >3 days/week
- •-Stroke within 1 month
- •-Any history of hemorrhagic or lacunar stroke
- •-Prosthetic heart valves
- •-Active cancer or cancer in complete remission from less than one year, except for treated early-stage squamous or basal cell skin carcinomas;
- •-Chronic liver disease
- •-Congenital or acquired bleeding disorders
- •-Uncontrolled severe (Stage 4) arterial hypertension
- •-Gastrointestinal complications (e.g., inflammatory bowel disease, esophagitis, gastritis and gastroesophageal reflux disease) and other disorders without active ulceration that can potentially lead to bleeding
- •-Recent major surgery (<1 month)
- •-Women with childbearing potential
研究者
相似试验
招募中
2 期
Treatment with rivaroxaban compared with warfarin in patients with acute coronary syndromeAcute coronary syndrome.Other acute ischemic heart diseasesIRCT20210614051574N9Esfahan University of Medical Sciences60
进行中（未招募）
1 期
Reduced-dosed rivaroxaban and standard-dosed rivaroxaban versus aspirin in the long-term prevention of blood clots from reccuring in the leg or lungong-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis and/or pulmonary embolismMedDRA version: 18.0Level: PTClassification code 10051055Term: Deep vein thrombosisSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 18.0Level: HLTClassification code 10037439Term: Pulmonary thrombotic and embolic conditionsSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 18.0Level: HLTClassification code 10034572Term: Peripheral embolism and thrombosisSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 18.0Level: PTClassification code 10037377Term: Pulmonary embolismSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2013-000619-26-DEBayer HealthCare AG2,850
进行中（未招募）
1 期
Reduced-dosed rivaroxaban and standard-dosed rivaroxaban versus aspirin in the long-term prevention of blood clots from reccuring in the leg or lungong-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis and/or pulmonary embolismMedDRA version: 19.0Level: PTClassification code 10051055Term: Deep vein thrombosisSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 19.0Level: HLTClassification code 10037439Term: Pulmonary thrombotic and embolic conditionsSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 19.0Level: HLTClassification code 10034572Term: Peripheral embolism and thrombosisSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 19.0Level: PTClassification code 10037377Term: Pulmonary embolismSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2013-000619-26-DKBayer AG3,300
进行中（未招募）
1 期
Reduced-dosed rivaroxaban and standard-dosed rivaroxaban versus aspirin in the long-term prevention of blood clots from reccuring in the leg or lungong-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis and/or pulmonary embolismMedDRA version: 16.1Level: PTClassification code 10051055Term: Deep vein thrombosisSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 16.1Level: HLTClassification code 10037439Term: Pulmonary thrombotic and embolic conditionsSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 16.1Level: HLTClassification code 10034572Term: Peripheral embolism and thrombosisSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 16.1Level: PTClassification code 10037377Term: Pulmonary embolismSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2013-000619-26-ITBayer HealthCare AG2,850
已完成
3 期
Reduced-dosed rivaroxaban and standard-dosed rivaroxaban versus ASA in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism The Einstein Choice StudySymptomatic venous tromboembolism / Blood clots10014523NL-OMON41605Bayer200