AtheroSclerotic Cardiovascular disEase Risk assessmenT and treAtment In AustraliaN Primary Care (VICTORION-ASCERTAIN: Implementation Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Effect on LDL-C Concentration
研究概览
简要总结
The goal of this study is to understand and compare an alternative model of care in comparison to the usual model of care in include male and female participants ≥18 years of age with a history of ASCVD (hear and blood vessels diseases) or high-risk participants who have elevated bad cholesterol (LDL-C ≥1.8 mmol/L). The alternative model of care includes telephone support calls from a study nurse (after visits 1,2 and 4) and text messages to your mobile phone with healthy heart information.
The main question it aims to answer is to understand and compare an alternative model of care in comparison to the usual model of care by evaluating the study participants bad cholesterol values after 180 and 365 days of the study.
Each participant will take their medications as per usual care but may have the addition of Inclisiran, 284 mg 1.5 ml liquid in a single-use prefilled syringe for under skin administration. In accordance with the current medical practice guidelines for treating heart related conditions, Inclisiran and its product information will be made available for use in both care models.
All the participants who decide to take part in this study will be requested to do the following:
- Answer any questions from the study doctor or the study staff as accurately as possible when asked about changes in health status, medications, heart health, visits to other doctors or hospital admissions, planned surgery, even if they think none of these are related to the study.
- Study doctor will be able to inform them of which medications you can and cannot take as part of this study.
- To use mobile phone to receive text messages and/or questionnaires as proposed in the new model of care.
- Advise the study doctor if they plan to move away from the geographical area where the study is being conducted during the study period.
- Take the medications for cholesterol lowering treatment (such as a statin and/or ezetimibe) that are prescribed by the study doctor.
- Tell the study doctor or study staff as soon as possible about suspected participant / participant partner pregnancy.
- Tell the study doctor or study staff if they change their mind about taking part in the study.
- Attend all the visits (screening visit, visits 1, 2, 3, 4 and visit 5).
- Provide all the information that will enable the study team to contact them, i.e., inform the study staff if contact details change, provide contact details of a family member, etc.
详细描述
ASCVD remains a significant burden in the Australian population. Moreover, based on recent local data, it is clear that there are still opportunities to improve the management of this condition in Australia.
In collaboration with leading experts in the field, analysis of the gaps in management of cholesterol in Australia has been undertaken. Key areas identified include Lack of regular lipid testing in general practice, Limited access to full range of management tools, current therapies aren't achieving clinical guidelines and poor medication adherence.
To address these pain points, the ASCERTAIN study will implement a new model of care that has been co-created with leading cardiologists in Australia and feedback has been provided by a General Practitioner (GP) Advisory Committee.
As the primary purpose of this study is to assess the impact of a new model of care compared to usual care, Inclisiran and its approved Product Information will be made available in both arms to be used as per the treating physician's discretion. Participants taking part in this study will receive maximally tolerated statin and/or ezetimibe therapy with or without other LDL-C lowering therapies as per the treating physician's discretion.
The primary clinical question of interest is:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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 must be obtained prior to participation in the study
- •Males and females ≥18 years of age
- •Documented History of ASCVD
- •a. Coronary heart disease (CHD):
- •Prior myocardial infarction
- •Prior coronary revascularisation (PCI or CABG)
- •b. Cerebrovascular disease:
- •Prior documented ischaemic stroke
- •Documented Carotid artery stenosis >70%
- •History of prior percutaneous or surgical carotid artery revascularisation.
- •c. Peripheral arterial disease (PAD):
- •History of prior percutaneous or surgical revascularisation of an iliac, femoral, or popliteal artery or aortic aneurysm in electronic patient history
- •Prior surgical amputation of a lower extremity due to peripheral artery disease.
- •OR ASCVD risk equivalents as per assessed by the online tool (>10% probability of CVD event within the next 5 years www.cvdcheck.org.au/calculator) or at clinically determined high risk.
- •Serum LDL-C above target ≥1.8 mmol/L (≥70 mg/dL) for ASCVD patients or ≥2.0 mmol/L for ASCVD risk equivalent patients
- •Not at Guideline directed cholesterol goals
- •On a stable dose of lipid-lowering therapy (such as a statin and/or ezetimibe) for ≥30 days before screening with no planned medication or dose change. Statin intolerant patients are eligible if intolerance is documented.
排除标准
- •Any medical or surgical history and or condition that might limit the individual's ability to take part in the study and/or put the participant at significant risk (according to physician's judgment).
- •Any underlying known disease, or surgical, physical, or medical condition that, in the opinion of the physician might interfere with the interpretation of the study results, including pregnancy.
- •Previous, current, or planned treatment with a monoclonal antibody targeting PCSK
- •Participants unable to access or unwilling to use mobile phone to receive text messages and/or questionnaires as proposed in the new model of care.
- •Participants who plan to move away from the geographical area where the study is being conducted during the study period.
结局指标
主要结局
Effect on LDL-C Concentration
时间窗: Baseline and 180 Days
LDL-C concentration at baseline and at day 180
次要结局
- Effect on LDL-C Concentration(365 Days)
研究者
Stephen Nicholls
Program Director of MonashHeart, Intensive Care and Victorian Heart Hospital
Monash University