ISRCTN48328178终止2 期
CXCR2 inhibition: a novel approach to treating coronary heart disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Men and women = 18 years of age
- •2. Angiographically proven coronary heart disease undergoing native-vessel PCI for non-ST-elevation myocardial infarction or unstable or stable coronary disease
- •3. Absolute blood neutrophil count at the time of PCI as well as 4 weeks after PCI of >4.0 x 109/L
- •4. Otherwise receiving standard of care for ischaemic heart disease (including appropriate anti-platelet therapy, statin, antihypertensive as clinically indicated)
排除标准
- •1. At any time after initial screening (ie at the time of PCI + IVUS), requirement or anticipated requirement, by clinical care guideline or in the opinion of the treating physician, for a new medication which may affect trial primary and / or secondary endpoints (ie specifically new lipid lowering therapy, anti-hypertensive therapy, or immunomodulatory therapy). Note that dose titration of chronic therapy initiated prior to PCI is permissible during the trial.
- •2. History of inability or, in the opinion of the investigator, anticipated inability to tolerate adenosine-based pharmacologic stress testing (e.g. active pulmonary broncho-constrictive disorder, second or third degree AV block without a cardiac pacemaker, resting systolic blood pressure <90mmHg, unstable coronary disease, use of medications which may interfere with the test)
- •3. Acute ST-elevation myocardial infarction
- •4. Prior cardiovascular surgery
- •5. Significant vascular anatomic abnormality which in the opinion of the investigator portends unacceptable risk to serial coronary IVUS examination
- •6. Scheduled inpatient surgery or planned hospitalisation during the study period
- •7. Any clinically significant disease or disorder (eg, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, psychiatric, major physical impairment) which, as judged by the investigator, might put the patient at risk because of participation in the study
- •8. Recurrent, latent, or chronic infections, as judged by the investigator, or with a history of osteomyelitis, or at risk of infection (surgery, trauma, or significant infection within 30 days before enrolment), or with a history of skin abscesses or a soft tissue infection within 60 days before enrolment
- •9. Evidence of active tuberculosis, either treated or untreated, or latent tuberculosis without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment
- •10. Positive test for serum hepatitis B surface antigen, hepatitis C antibody, or HIV
- •11. Patients vaccinated with a live or live-attenuated vaccine in the 2 weeks prior to enrolment
- •12. Use of any immunosuppressive treatment (eg, methotrexate, troleandomycin oral gold, cyclosporine, azathioprine, intramuscular long-acting corticosteroid [except for asthma exacerbations]) within 60 days prior to enrolment
- •13. Prior solid organ or bone marrow transplantation
- •14. History of any primary immunodeficiency disorder excluding asymptomatic selective IgA or IgG subclass deficiency
- •15. Active malignancy or neoplastic disease in the previous 5 years other than superficial basal cell carcinoma
- •16. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level =2.5 times the upper limit of normal (ULN) 4 weeks after PCI
- •17. QTc of >450 ms for males and 470 ms for females 4-weeks after PCI
- •18. Current evidence of drug abuse or significant history of drug abuse, as judged by the investigator.;
- •19. Current evidence of alcohol abuse or a significant history of alcohol abuse, as judged by the investigator
- •20. Pregnancy or breast feeding during the study
- •21. Contraindication to any of the study tre
研究者
相似试验
进行中（未招募）
1 期
Inhibition of white cells as a new treatment for coronary heart diseaseEUCTR2016-000775-24-GBKing's College London102
Unknown
3 期
Effect Observation Study of COX-2 Inhibitor to Treat Primary Hypertrophic OsteoarthropathyPrimary Hypertrophic OsteoarthropathyNCT02438709Peking Union Medical College Hospital30
进行中（未招募）
1 期
Clinical trial of whether AZD5069 combined with immunotherapy (durvalumab) is effective for patients with advanced primary liver cancerAdvanced liver cancerMalignant neoplasm of liver and intrahepatic bile ductsCancerISRCTN12669009HS Greater Glasgow and Clyde47
已完成
不适用
The direct effects of non-steroidal anti-inflammatory drugs (NSAIDS) on osteoarthritic knee cartilageOsteoarthritisISRCTN90366351niversity Medical Centre Utrecht (UMCU) (Netherlands)42
已完成
不适用
Evaluation of selective COX-2 inhibitor for the protection of intestinal mucosal damage in comparison to NSAID in patients with rheumatoid arthritis (Investigation by capsule endoscopy and measurement of biomarkers for rheumatoid arthritis)JPRN-UMIN000002554Osaka University30