Lipid target achievement in high risk patients with Coronary Heart Disease (DYSIS II ACS/CHD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Merck Co Inc
- 入组人数
- 10,500
- 试验地点
- 25
- 主要终点
- The primary objective of this observational study is to document real life lipid levels in patients with stable CHD (stable CHD or ACS)
研究概览
简要总结
Patients withcoronary heart disease (CHD) are considered to be at very high risk forsubsequent adverse cardiovascular events. Long-term treatment of cardiovascularrisk factors such as hyperlipidemia, hypertension as well as diabetes are keyfactors to avoid the progress of CHD and its complications.
Data ontreatment for secondary prevention in clinical practice was first provided bythe EuroAspire Survey as part of the Euro Heart Survey program showing animprovement of guideline adherence over time, however, with evident room forimprovement. The 2L-Registry conducted in Germany documented large deficienciesin the lipid lowering treatment for secondary prevention in the hospital aswell as in the outpatient setting (Gitt et al., Clin Res Cardiol. 2011 Apr;100(4):277-87 and Gitt et al., Eur J Cardiovasc Prev Rehabil. 2009Aug;16(4):438-44).
Themanagement of ACS has been rapidly evolving during the past few decades. Theintroduction of primary PCI as well as advanced anti-thrombotic andanti-platelet treatments resulted in a significant improvement of acute outcomein these patients. However, patients surviving an ACS will continue to be athigh risk for subsequent events.
In 2011, the EuropeanSociety of Cardiology (ESC) and the European Artherosclerosis Society (EAS)published new guidelines for the management of dyslipidemias (European HeartJournal (2011) 32, 1769–1818) acknowledging data from recent randomized trials.These new guidelines set the target for LDL-cholesterol to <70mg/dl forpatients with CHD.
DYSIS II willdocument the lipid target achievements and the prevalence of dyslipidemias inpatients with stable CHD and in patients surviving any ACS regardless ofwhether they are treated with lipid-modifying therapy or not. the proposedDYSYS-II (ACS/CHD) is purely observational study wherein NO treatment will begiven to patients / or NO medical procedures would be undertaken. The study does not recommend or discourage any treatments, procedures,diagnostics or examinations in routine patient care management.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •DYSIS II ACS • Age ≥ 18 years • Hospitalized for acute coronary syndrome (ACS) (ST segment elevation myocardial infarction (STEMI), left bundle branch block (LBBB), Non-ST elevated myocardial infarction (NSTEMI), unstable angina) at time of enrolment • Full lipid profile available based on blood drawn within 24 hours of admission to the hospital.
- •â€¢ On lipid-modifying therapy (LMT) for equal to or more than 3 months at time of enrolment, or NOT at all on LMT.
- •DYSIS II CHD • Age ≥ 18 years • Documented CHD by at least one of the following: o coronary angiography (stenosis >50%) o cardiac computed tomography (CT) (stenosis > 50%) o prior percutaneous coronary intervention (PCI) or prior coronary artery bypass graft (CABG) o history of ACS >3 months prior to enrolment o Complete fasting lipid profile 0-12 months prior to enrollment while on lipid modifying therapy (LMT) for equal to or more than 3 months or not at all on LMT.
排除标准
- •DYSIS II ACS • Patients treated with lipid-modifying therapy for more than 0 but less than 3 months at the time of enrolment DYSIS II CHD • History of ACS within 3 months prior to enrollment • Participation in DYSIS II ACS.
结局指标
主要结局
The primary objective of this observational study is to document real life lipid levels in patients with stable CHD (stable CHD or ACS)
时间窗: Time point for assessment for Stable CHD is when patient report or visit to treating physician for routine follow-up | Time Point for Data collection of ACS patients - When patient is discharged after successful ACS treatment. Thereafter telephonic follow-up 16 weeks post discharge
次要结局
- •To describe patient characteristics and risk profiles (associated comorbidities) in patients with stable CHD specifically chronic kidney disease (CKD stages 3-5) and type 2 diabetes mellitus (T2DM) and survivors of ACS(•To document drug utilization patterns for patients with CHD and among CHD subgroups (stable CHD, ACS, CKD, T2DM))