跳至主要内容
临床试验/CTRI/2022/05/042446
CTRI/2022/05/042446已完成不适用

Hypercholesterolemia in Acute Coronary Syndrome Patients in India - A Retrospective Real- World Evidence Study

Novartis Healthcare Private Limited11 个研究点 分布在 1 个国家目标入组 558 人开始时间: 2022年6月6日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
558
试验地点
11
主要终点
To assess LDL-C control (less Than 55 mg/dL) in patients with ACS with current available treatments

研究概览

简要总结

  1. Cardiovascular disease (CVD) is leading cause of death worldwide, accounting for about 31% of global death (WHO, 2018)

  2. In India, CVD is responsible for about 27% of all deaths (WHO, 2018)

  3. Atherosclerosis cardiovascular disease (ASCVDs) are associated with a substantial mortality, physical morbidity, and mrtal disability. India has been experiencing an epidemic of ASCVD, which has suppressed infectious diseases as the leading cause of death among Indians.

Elevated plasma low-density lipoprotein cholesterol (LDL-C) level play a major role in the pathophysiology of ASCVDs ( Auer and Berent,2018)

  1. No major study exists currently that could hlep identify the level of LDL-C control amongst Indian acute Coronary syndrome (ACS) patients, especially as per the revised LAI consensus and other global guidelines.

  2. The present study is therefore being conducted to evaluate the real world experience related to the treatment patterns and LDL-C control in ACS patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients aged >18 years.
  • Patients with ACS event [One or more of the following: ST-segment-elevation myocardial infarction or left bundle branch block myocardial infarction (STEMI/LBBB MI), a non-ST-segment-elevation myocardial infarction (NSTEMI), or UA with or without PCI/ CABG.
  • Lipid profile data available at index date/15 days of index date and at least once at 3, 6, 9, 12 months post-index date ACS event.

排除标准

  • Patients meeting any of the following criteria will not be included in the study:
  • Incomplete paper-based records/EMRs data.
  • Non-availability of paper-based records/EMRs for 12 months’ time point post index date ACS event.

结局指标

主要结局

To assess LDL-C control (less Than 55 mg/dL) in patients with ACS with current available treatments

时间窗: Time Frame: Baseline, Months 3, 6, 9, and 12

次要结局

  • In patients with ACS with current available treatments(A. To Assess LDL-C control (Less Than 30, Less Than 50, Less than 70, Less Than 100 mg/dL) B. To assess Lp(a) testing and control C. To study the change in lipid profile parameters D. To assess treatment pattern of statin positive or negative, other lipid lowering drugs, statin intolerance E. To assess tolerability-of LLTs F. To assess demographic profile, clinical characteristics, and concomitant medications)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (11)

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