EUCTR2016-000211-33-GB进行中（未招募）1 期
Dose Effect Relationship of a Single Dose of Rituximab on the Kinetics of B Lymphocytes in Patients with Acute ST-Segment Myocardial Infarction - RITA-MI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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
- •1. Age 18-75 years old
- •2. Acute anterior STEMI and successful primary percutaneous coronary intervention (PCI) with stent inplantation in the culpirt lesion during the first 24hrs after onset of symptoms
- •3. Provision of written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. Previous history of STEMI
- •2. Cardiogenic shock (systolic blood pressure <80mmHg; unresponsive to fluids, or necessitating catecholamines) electrical instability or severe congestive heart failure
- •3. corrected QT interval >500msecs using Bazett's formula
- •4. Hematologic abnormalities (hemoglobin <10g/dL or hematocrit <30%, platelet cell count of <100x10(3)/uL, white blood cell count <4x10(3)/uL)
- •5. Renal failure (estimated GFR by the MDRD formula <45ml/min/1.73m2)
- •6. Known hepatic failure or abnormal liver function tests at baseline (ALT>2xULN)
- •7. Active or recurrent hepatitis (type B)
- •8. Known HIV infection
- •9. Current or previous tuberculosis (CXR)
- •10. Current infections
- •11. Presence or history in the previous five years of an ongoing cancer, except in situe cancer of the cervix or basal cell carcinoma
- •12. Any oral or intravenous immunosuppressive treatment (other than concomitant 100mg methylprednisolone), disease modifying drugs or other immue modulatory monoclonal antibodies
- •13. Allergy to rituximab or one of its excipients
- •14. Expected need for vaccination with a live attenuated vaccine during the study including incomplete vaccination courses
- •15. Known or suspected preganacy at screening or lactating women
- •16. Women of childbearing age unless confirmed by direct questioning that they are reproductively sterile or post menopausal
- •17. Participation in other clinical trials
- •18. Inability to comply with study procedures
研究者
相似试验
已完成
3 期
The effect of adding fenofibrate to phenobarbital in the treatment of prolonged neonatal jaundiceProlonged neonatal jaundice.IRCT20201118049433N1Islamic Azad University60
进行中（未招募）
4 期
effect of dexamethasone in reducing pain after gall bladder operatioCTRI/2016/10/007362Dr Surendra Singh100
尚未招募
不适用
A study to compare the effect of low dose versus conventional dose intrathecal fentanyl with hyperbaric bupivacaine on the block characteristics in parturient undergoing caesarean section under spinal anaesthesiaCTRI/2021/08/035932airikyengbam Sheityajit Roy
已完成
不适用
The Comparison Study Of The Effect Of One Dose And Two Doses Of Trichloroacetic Acid 85% In Cervical Intraepithelial Neoplasia TreatmentPremalignant lesions of Cervix.Dysplasia Of Cervix UteriIRCT20171128037651N1Oroumia University of Medical Sciences50
进行中（未招募）
1 期
An investigation of the efficacy of a single dose of insulin in the prevention of excessive cutaneous scarring in breast surgery patients - Insulin as anti-scarring agent - breast surgery groupScarring arising from non cancer-related bilateral breast surgeryEUCTR2010-022290-34-GBPharmecosse75