A Phase IIIb, Multicentre, Randomised Controlled Study to Evaluate the Implementation, Preference and Utility for Administration of Inclisiran Sodium in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD-risk Equivalents and Elevated Low Density Lipoprotein Cholesterol (LDL-C) Using a Primary Care Models in the NHS.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 892
- 试验地点
- 1
- 主要终点
- Percentage Change in LDL-C From Baseline to Day 270
研究概览
简要总结
The purpose of this study was to evaluate the implementation of inclisiran in a regional primary care setting in the UK
Inclisiran, also known as KJX839, is a medication made to reduce the level of "bad" cholesterol (LDL-cholesterol) in the blood. Inclisiran works in a way that makes the liver produce less of a substance called 'PCSK9'. PCSK9 reduces the ability of the liver to remove LDL-cholesterol from the blood. By lowering the production of PCSK9, Inclisiran leads to more LDL-cholesterol being removed by the liver from the blood, thereby reducing LDL-cholesterol overall.
详细描述
A phase IIIb, multicenter, randomized controlled study to evaluate the implementation, preference, and utility for administration of inclisiran sodium in participants on established lipid lowering medication or, have been recommended lipid lowering therapy by their healthcare provider but are unable to tolerate treatment, with elevated low density lipoprotein cholesterol (LDL-C) in a primary care population. This study was an implementation research study that utilized implementation science methodology and use of the electronic medical record (EMR).
Using implementation science methodology, the study intended to assess the effect of 9 months treatment with inclisiran with/without behavioural support, compared to standard of care + behavioural support, on LDL-C reduction, total lipid profile, assessments of patient and healthcare professional (HCP) satisfaction, health-care resource utilization and healthcare service process evaluation.
The primary focus of this study was implementation and 'transactability' - how to organize, deliver and maintain an innovative treatment for Atherosclerotic Cardiovascular Disease (ASCVD) in a primary care setting in a sustainable way.
Patients taking part in the study were randomised to one of three groups:
- Control + BS: Participants continued to receive their background lipid lowering therapy plus behavioural support. Subjects in treatment group 1 were referred to as the control group in this study
- Inclisiran: Participants continue to receive their background lipid lowering therapy, plus inclisiran for injection (delivered in an injection-only model).
- Inclisiran + BS: Participants continued to receive their background lipid lowering therapy, plus inclisiran for injection, plus behavioural support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Open-Label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent had to be obtained prior to participation in the study.
- •Patients on established lipid lowering medication or, have been recommended lipid lowering therapy by their health care provider but were unable to tolerate treatment.
- •A total cholesterol measurement at screening that was ≥4 mmol/L [approximately 160 mg/dL].
- •Participants on lipid-lowering therapies had to be on a stable dose for ≥30 days before screening with no planned medication or dose change.
排除标准
- •Medical or surgical history that might limit the individual's ability to take study treatments for the duration of the study and/or put the participant at significant risk .
- •Current or planned renal dialysis or transplantation.
- •Acute coronary syndrome or stroke less than 4 weeks before the screening visit.
- •Coronary revascularization procedure planned within the next 6 months.
- •Women of child-bearing potential, unless they agree to abstinence or, if sexually active, agree to the use of effective methods of contraception during the study.
- •Women who are pregnant or breast-feeding.
- •Previous, current or planned treatment with a monoclonal antibody targeting PCSK9, or with a drug known to be contra-indicated with inclisiran.
- •Previous exposure to inclisiran or participation in a randomised study of inclisiran.
- •Current or previous participation in a clinical study with an unlicensed drug or device within 30 days or five half-lives of the screening visit, whichever is longer.
- •Participants who planed to move away from the geographical area where the study is being conducted during the study period.
- •A triglyceride measurement at screening that is greater than or equal to 4.52 mmol/L
研究组 & 干预措施
Inclisiran
Participants continue to receive their background lipid lowering therapy, plus inclisiran for injection (delivered in an injection-only model).
干预措施: Background lipid lowering therapy (Drug)
Control+ BS
Participants continued to receive their background lipid lowering therapy plus behavioural support (BS).
干预措施: Behavioural Support (Behavioral)
Control+ BS
Participants continued to receive their background lipid lowering therapy plus behavioural support (BS).
干预措施: Background lipid lowering therapy (Drug)
Inclisiran
Participants continue to receive their background lipid lowering therapy, plus inclisiran for injection (delivered in an injection-only model).
干预措施: Inclisiran (Drug)
Inclisiran + BS
Participants continued to receive their background lipid lowering therapy, plus inclisiran for injection, plus behavioural support.
干预措施: Inclisiran (Drug)
Inclisiran + BS
Participants continued to receive their background lipid lowering therapy, plus inclisiran for injection, plus behavioural support.
干预措施: Behavioural Support (Behavioral)
Inclisiran + BS
Participants continued to receive their background lipid lowering therapy, plus inclisiran for injection, plus behavioural support.
干预措施: Background lipid lowering therapy (Drug)
结局指标
主要结局
Percentage Change in LDL-C From Baseline to Day 270
时间窗: Baseline, Day 270
Change in Low Density Lipoprotein Cholesterol (LDL-C) after 270 days of treatment in adults on established lipid lowering medication or who have been recommended lipid lowering therapy by their health care provider but are unable to tolerate treatment, regardless of treatment discontinuation for any reason and regardless of unforeseen change in the concomitant lipid lowering therapy. Multiple imputation is used to impute missing data using a washout model.
次要结局
- Number of Participants Interviewed for CFIR Analysis.(Day 270)
- Patient Reported Outcomes: CSQ-8 Total Score After Treatment(Day 90)
- Patient Reported Outcomes: CSQ-8 Total Score Between Inclisiran Arms(Day 90)
- Change From Baseline to Day 90 in Total PAM Score(Baseline, Day 90)
- Change From Baseline to Day 90 in Total PAM Score Between Inclisiran Arms(Baseline, Day 90)
- Measures of Adherence to Cardiovascular Disease Self-management Using the Validated Patient Activation Measure (PAM) Questionnaire.(Baseline, Day 90)