Implementation of an Algorithm- and Multi-professional Team-supported Strategy to Improve Lipid Management of Patients With Atherosclerotic Cardiovascular Disease: OPTIMIZE ASCVD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The between group difference in LDL-C percent change
研究概览
简要总结
This is a randomized, controlled, collaborative, multicenter, pilot implementation science study evaluating the hypothesis that algorithm- and multi-professional team-supported lipid management reduces low density lipoprotein-cholesterol (LDL-C) compared with usual care in patients with atherosclerotic cardiovascular disease (ASCVD).
详细描述
OPTIMIZE-ASCVD is a randomized, controlled, collaborative, open-label, multicenter pilot implementation science study evaluating the hypothesis that algorithm- (Appendix A) and multi-professional team-supported lipid management reduces LDL-C compared with usual care in patients with ASCVD.
Approximately 100 participants will be randomized (1:1).
- Participant preference for injectable vs oral lipid therapy will be recorded at baseline.
- Participants allocated to algorithm-and multi-professional team-supported lipid management will be evaluated by a physician and prescribed lipid therapy which aims to achieve LDL-C target without titration. Participants will be contacted by a pharmacist to provide education about the medication and support any access issues.
- Participants allocated to usual care will be referred for management by their usual care provider who will receive a summary of guideline recommendations
The study will include decentralized clinical trial features including use of local, Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories for blood tests, use of data extracted from the electronic medical record (EMR), electronic collection of patient-reported outcomes (PRO) and remote conduct of study activities. As an open label study with both strategy groups receiving GDMT, no Data and Safety Monitoring Committee will be convened. Study leadership will monitor aggregate data during the trial and may modify the sample size and/or cap enrollment of subgroups to ensure consistency with design assumptions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Provided informed consent
- •Age >18 years inclusive at screening
- •Documented atherosclerotic vascular disease including:
- •Coronary artery disease (prior revascularization, myocardial infarction, imaging evidence of coronary atherosclerosis)
- •Peripheral artery disease (prior revascularization, amputation, ankle: brachial index (ABI) ≤ 0.90, imaging evidence of extra-coronary atherosclerosis)
- •Carotid artery disease (prior endarterectomy or stenting of the extracranial carotid artery or imaging evidence of carotid atherosclerosis)
- •Imaging evidence of atherosclerotic vascular disease in a non-coronary vascular bed (e.g. aorta, mesenteric, renal)
- •LDL-C >70mg/dL
排除标准
- •Any reason that, in the opinion of the investigator, the patient would be unable to adhere to the protocol for the duration of the study (e.g. terminal diagnosis, metastatic cancer) or in whom participation might result in harm.
- •Planned active titration of current lipid-lowering therapy
- •Myocardial infarction or arterial revascularization within prior 30 days
研究组 & 干预措施
Control: Guideline-directed lipid management by usual care provider
干预措施: Guideline-directed lipid management by usual care provider (Other)
Algorithm- and multi-professional team-supported lipid management
干预措施: Algorithm- and multi-professional team-supported lipid management (Other)
结局指标
主要结局
The between group difference in LDL-C percent change
时间窗: Baseline to 3 months
次要结局
- Between group difference(1, 3 and 6 months)
- Between group difference(Baseline to 1 and 6 months)