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临床试验/NCT01770210
NCT01770210已完成不适用

A Multicenter, Open-label, 30-week Observational Clinical Study to Examine the Progress of Patients After Leaving the Cardiology Clinic or Unit Due to Acute Cardiovascular Event.

Elpen Pharmaceutical Co. Inc.12 个研究点 分布在 1 个国家目标入组 670 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
670
试验地点
12
主要终点
Change of LDL-C, HDL-C, T-CHOL from baseline to the end of the study by atorvastatin dosage scheme

研究概览

简要总结

In western societies hypercholesterolemia is one of the major and independent factors that predispose to cardiovascular disease and death from them. According to the clinical study ATTICA, conducted during the years 2001-2002, in which randomized 1514 men and 1528 women, rates of hypercholesterolemia observed in a sample of urban population was 39% for men and 37% women . The prevalence in the corresponding U.S. epidemiological study NIANES was 52% for men and 49% women. The relationship between cholesterol, lipid-lowering therapy and risk of cardiovascular disease appears to be quite clear in the secondary prevention trials, the 4S (Scandinavian Simvastatin Survival Study), CARE (Cholesterol And Recurrent Events) and LIPID (Long-term Intervention with Pravastatin in Ischemic Disease) which showed the benefits of lowering LDL cholesterol in patients with coronary artery disease. Despite these remarkable results, studies were secondary prevention as a major shortcoming, the lack of patients with acute coronary events. This gap came to cover the study MIRACL (Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering). In MIRACL study , atorvastatin 80 mg was evaluated in 3,086 patients (atorvastatin n = 1.538, placebo n = 1.548), acute coronary syndrome (myocardial infarction without Q-wave or unstable angina). Treatment was initiated during the acute phase after hospital admission and lasted for a period of 16 weeks. Treatment with atorvastatin 80 mg / day increased the latency of the combined primary endpoint, defined as death from any cause, nonfatal myocardial infarction, resuscitated cardiac arrest, or angina with objective evidence of myocardial ischemia requiring admission to hospital, indicating a risk reduction of 16% (p = 0,048). This was mainly due to a 26% reduction in re-hospitalization for angina with objective evidence of myocardial ischemia. The other secondary endpoints were not statistically significant by themselves (total: placebo: 22.2%, Atorvastatin: 22.4%).

Statins by reducing coronary syndromes, it appears that contribute to reducing the incidence of cardiovascular diseases. This is exactly what was observed in 4S, in which the incidence of chronic heart failure (CHF) during follow-up was 10.3% for those who received placebo and 8.3% in the simvastatin group, a finding which translates 19% reduction in heart failure (P <0,015) nationwide with the appearance episode (event) CV.

详细描述

Determination of cardiovascular risk

If the assessment of cardiovascular risk remains incomplete, can identify indicators that measure risk:

  1. Framingham Risk Score: Includes age, sex, total and HDL-CHOL, and levels of blood pressure (can underestimate the risk in some patients).
  2. PROCAM Risk Score: also includes triglycerides, fasting glucose tolerance and family history.
  3. Reynolds Risk Score: Includes family history and levels of hsCRP.
  4. Greek Score (www.hearts.org / greece). People with low risk The Framingham Risk Score shows <10% chance of cardiovascular disease over the next 10 years. Dealing mainly with healthy dietary intervention or drugs when the levels of LDL-CHOL> 190 mg / dL or atherogenic index (T-CHOL/HDL-CHOL)> 6.

Medication is necessary in individuals with familial hypercholesterolemia to reduce the LDL CHOL <100 mg / dL. For this reason, a careful family history taking physical examination. The Reynolds Risk Score may reclassify their low-risk patients at higher risk individuals.

Persons moderate risk This group includes mostly middle-aged people. The Framingham Risk Score shows 10-19% chance of cardiovascular disease over the next 10 years. However, a positive family history and high hsCRP (if available) can modify the level of risk. These people need to change my lifestyle for 3 months, but may then be necessary pharmacological lipid-lowering therapy in people with at least two major risk factors and levels of LDL-CHOL> 130 mg / dL. The administration of lipid-lowering therapy in people with levels of LDL-CHOL 100-129 mg / dL is recommended for people with multiple cardiometabolic risk factors (visceral obesity, prediabetes, hypertension, etc.). The increase of atheromatic index (> 5) and the presence of high (> 2 mg / L) levels of CRP (if available) are also indications for lipid lowering regardless of the levels of LDL-CHOL.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Outpatients (External Ambulatory) Patients.
  • Male or female patients
  • 18 to 99 years
  • Patients with Hypercholesterolemia
  • Patients with and without treatment with statin
  • Patients enrolled in any of the study sites with acute cardiovascular event
  • Patients discharged with study medication (Antorcin ®)
  • Patients who have agreed and signed the consent form for the recording and processing of their personal data.

排除标准

  • Patients under 18 and over 99 years.
  • Women in pregnancy or lactation period
  • Patients enrolled in any of the study sites for any reason other than an acute cardiovascular event
  • Patients who discharged and take another statin drug formulation other than the study drug formulation (Antorcin ®)
  • Patients who have not consented and signed the consent form for the recording and processing of their personal data.

研究组 & 干预措施

Cardiovascular events

Patients on atorvastatin treatment hospitalised due to cardiovascular events

干预措施: Patients on atorvastatin treatment (Drug)

结局指标

主要结局

Change of LDL-C, HDL-C, T-CHOL from baseline to the end of the study by atorvastatin dosage scheme

时间窗: 0 months, 1-1,5 months, 4-4,5 months, 7-7,5 months

Achieving the level of lipids (LDL-C, HDL-C, T-CHOL) in blood plasma of patients in the atorvastatin dosage: those who received the 40 mg dose and those who received a dose of 80 mg

Change of lipids (LDL-C, HDL-C, T-CHOL)levels from baseline to the end of the studyCHOL) plasma blood Evaluation of atorvastatin (Antorcin) treatment per study subgroup

时间窗: 0 months, 1-1,5 months, 4-4,5 months, 7-7,5 months

The evaluation of atorvastatin treatment to all patients with cardiovascular events and separate the two subgroups (diabetes type II patients with metabolic syndrome) in order to achieve the level of lipids (LDL-C, HDL-C, T-CHOL) plasma blood

次要结局

  • Measurement of days without treatment - Patients' compliance(0 months, 1-1,5 months, 4-4,5 months, 7-7,5 months)
  • Number of Adverse Events during study duration(0 (baseline), 7-7,5 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (12)

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