ISRCTN88876914进行中（未招募）3 期
A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease (ORION-4)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 16,124
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
- •History or evidence of at least one of the following:
- •1. Prior MI
- •2. Prior ischemic stroke
- •3. Peripheral artery disease as evident by prior lower extremity artery revascularization or aortic aneurysm repair
- •4. Minimum age of 40 years for men and 55 years for women. (added 21/09/2022)
排除标准
- •None of the following must be satisfied (based on self-reported medical history):
- •1. Acute coronary syndrome or stroke less than 4 weeks before the Screening visit or during the Run-in period
- •2. Coronary revascularization procedure planned within the next 6 months
- •3. Known chronic liver disease
- •4. Current or planned renal dialysis or transplantation
- •5. Previous exposure to inclisiran or participation in a randomized trial of inclisiran
- •6. Current participant exclusion criterion as of 15/01/2020: Previous (within about 3 months), current or planned treatment with a monoclonal antibody targeting PCSK9, or with a drug known to be contra-indicated with inclisiran (none currently known).
- •Previous participant exclusion criterion: Previous, current or planned treatment with a monoclonal antibody targeting PCSK9, or with a drug known to be contra-indicated with inclisiran (none currently known)
- •7. Known to be poorly compliant with clinic visits or prescribed medication
- •8. Medical history that might limit the individual’s ability to take trial treatments
- •for the duration of the study (e.g. severe respiratory disease; cancer or evidence of spread within approximately the last 5 years, other than nonmelanoma skin cancer; or history of alcohol or substance misuse) or may put the individual at significant risk in the opinion of the investigator (or their authorised deputy) if he/she were to participate in the trial
- •9. Women of child-bearing potential, current pregnancy, or lactation
- •10. Current participation in a clinical trial with an unlicensed drug or device
- •11. Staff personnel directly involved with the study and any family member of the investigational study staff
研究者
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