NL-OMON49134已完成3 期
The inflammatory response of monocytes and neutrophils to Crystals after Low dose colchicine in patients with coronary artery disease - CrystaLo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
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
- 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:
- •* Have suffered from type 1 myocardial infarction
- •* Have been clinically stable for at least three months
- •* Provided 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:
- •* Age below 18 years or above 80 years
- •* Use of CYP3A4 or P-glycoprotein inhibitors such as macrolids (claritromycin
- •and erytromycin), ciclosporin, ketoconazol, itraconazol, voriconazol, HIV
- •protease inhibitors, calciumchannel antagonists such as verapamil and diltiazem
- •* Women who are pregnant, breast feeding or may be considering pregnancy during
- •the study period or six month after the end of study participation
- •* Male patients who may be considering conceiving during the study period or
- •before six months after the end of study participation
- •* Have renal impairment as evidenced by a serum creatinine >150 *mol/l or eGFR
- •<50mL/min/1.73m2)
- •* Have an elevated inflammatory profile as evidenced by a hsCRP >10mg/l in
- •order to exclude patients with intercurrent (subclinical) infections
- •* Have a moderate to severe hepatic disease
- •* Suffer from pre-existing chronic gastro-intestinal complaints which might
- •obscure signs of colchicine toxicity
- •* Malignant disease in past five years or any medical condition that could
- •interfere with the conduct of the study in the opinion of the investigator.
- •* Chronic or recent (<1 month) infections and/or clinical signs of acute
- •* Suffering from auto-immune / inflammatory diseases
- •* Chronic use of immunosuppressants or anti-inflammatory drugs, including
- •* A history of haematological malignant disease
- •* Recent hospital admission or surgery with general anaesthesia (<3 months)
- •* Previous vaccination within 1 month prior to study entry
- •* Inability or unwillingness to comply with the protocol requirements, or
- •deemed by investigator to be unfit for the study.
- •* Are currently enrolled in a competing trial
研究者
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