NL-OMON50625已完成4 期
Trained immunity by dual-pathway inhibition (low-dose rivaroxaban and acetylsalicylic acid) in coronary artery disease - DUALCAD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •- Stable CAD
- •- with an indication for single antiplatelet therapy according to international
- •(ESC) guidelines,
- •- at least16 years old
- •- Written informed consent
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- Use of more intensive antithrombotic treatment (dual antiplatelet therapy,
- •dual-pathway inhibition, direct oral anticoagulants, vitamin k antagonists)
- •- Contra-indication to rivaroxaban
- •o Hypersensitivity to rivaroxaban
- •o at significant risk for major bleeding
- •* current gastrointestinal ulceration
- •* presence of malignant neoplasms, with the exception of non-melanoma skin
- •* recent (<2 months) brain or spinal injury
- •* recent (<3 months) brain or spinal surgery
- •* recent (<3 months) intracranial, gastrointestinal or pulmonary hemorrhage
- •* presence of arteriovenous malformations,
- •* major intraspinal or intracerebral vascular abnormalities
- •* congenital or acquired bleeding disorders
- •* uncontrolled severe arterial hypertension (180 mmHg or more systolic, or 110
- •mmHg or more diastolic)
- •o Severe hepatic disease: Child Pugh B or C
- •o Severe kidney failure: estimated glomerular filtration rate <15 ml/min or
- •requiring dialysis
- •o severe heart failure with known ejection fraction < 30% or New York Heart
- •Association class III or IV symptoms
- •o concomitant treatment with medication with a strong pharmacokinetic
- •interaction with rivaroxaban, leading to contra-indication according to the
- •*regionale_NOAC_richtlijn* [11]
- •- Pregnant or breastfeeding women
- •- Unable to give informed consent
研究者
相似试验
进行中（未招募）
1 期
The effect of rivaroxaban in addition to aspirin on the immune system in coronary artery diseasecoronary artery diseaseEUCTR2021-006189-19-NLRadboudumc20
已完成
不适用
Randomised comparison of two different immunosuppressive regimens on progression of arteriosclerosis in renal transplant patients. Extension of NOCTX-study: Is progression of arteriosclerosis in ESRD patients inhibited by nocturnal hemodialysis or renal transplantation?cardiovascular disease in renal transplant patientsvascular calcification in renal transplant patients100110821002914910003216NL-OMON37133Dianet Dialysecentra, lokatie Utrecht13
已完成
不适用
A Phase I-II study of virus neutralizing antibodies against SARS-CoV-2. A focus on convalescent plasma and hyperimmune anti-SARS-CoV2 immunoglobulinesNL-OMON51004Erasmus MC, Universitair Medisch Centrum Rotterdam44
已完成
不适用
An open-label, adaptive multiple-dose study to investigate the pharmacokinetics and pharmacodynamics of RO7234292 in csf and plasma, and safety and tolerability following intrathecal administration in patients with Huntington's disease.Chronic Progressive Choreadegenerative chorea1002929910029317NL-OMON49037Hoffmann-La Roche4
已完成
4 期
Infection prevention and immune modulation by bacterial lysates in patients with asthma: gaining insight into the mechanism of an old therapyreactive airway disease1001981510006436asthmaNL-OMON43072Sint Franciscus Gasthuis75