EUCTR2016-000775-24-GB进行中（未招募）1 期
CXCR2 inhibition: a novel approach to treating coronary heart disease - CXCR2 inhibition and coronary disease / CICADA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 102
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
- •Men and women = 18 years of age.
- •Angiographically proven coronary heart disease undergoing native-vessel PCI for myocardial infarction or unstable or stable coronary disease.
- •Absolute blood neutrophil count at the time of PCI as well as 4 weeks after PCI of = 3.0 x 109/L.
- •Otherwise receiving standard of care for ischaemic heart disease (including appropriate anti-platelet therapy, statin, antihypertensive as clinically indicated).
- •Women of childbearing potential may be included in the study provided they are established on, and continue to use highly effective contraceptive methods (as defined in section 6.2.1) from the time of screening until 1 week after the final dose of study drug. Women will be considered post-menopausal if they are:
- •ounder 50 years of age and have been amenorrhoeic for 12 months or more (following cessation of exogenous hormonal treatments – if these have been previously taken) and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range, or
- •o= 50 years old and have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments
- •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 102
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 102
排除标准
- •At any time after initial screening (i.e. 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 (i.e. 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.
- •History of inability or, in the opinion of the investigator, anticipated inability to tolerate pharmacologic stress testing (e.g. 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).
- •Significant vascular anatomic abnormality which in the opinion of the investigator portends unacceptable risk to serial coronary IVUS and ComboWire examination.
- •Scheduled inpatient surgery or planned hospitalisation during the study period.
- •Any clinically significant disease or disorder (e.g., 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.
- •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 hist ory of skin abscesses or a soft tissue infection within 60 days before enrolment.
- •Evidence of active tuberculosis, either treated or untreated, or latent tuberculosis without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment.
- •Positive test for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.
- •Patients vaccinated with a live or live-attenuated vaccine in the 2 weeks prior to enrolment.
- •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.
- •Prior solid organ or bone marrow transplantation.
- •History of any primary immunodeficiency disorder excluding asymptomatic selective IgA or IgG subclass deficiency.
- •Active malignancy or neoplastic disease in the previous 5 years other than superficial basal cell carcinoma.
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level =2.5 times the upper limit of normal (ULN) 4 weeks after PCI.
- •QTc of >450 ms for males and >470 ms for females 4-weeks after PCI.
- •Current evidence of drug abuse or significant history of drug abuse, as judged by the investigator.
- •Current evidence of alcohol abuse or a significant history of alcohol abuse, as judged by the investigator.
- •Pregnancy or breast feeding during the study.
- •Contraindication to any of the study treatments or known or suspected hypersensitivity to the investigational product, compounds of the same class, other study treatments or any excipients as specified in Section 5.7.
- •Unwilling, or unable, to give informed consent.
研究者
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