Clinical trial NCT02561845: Effectiveness of Statins on Lipid Goal Attainment and Lipid Parameters in PCI Patients
Official title: Effectiveness of Statins on Lipid Goal Attainment and Lipid Parameters in Percutaneous Coronary Intervention Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: PCI Patients
Keywords: Effectiveness of statins, on lipid goal attainment and lipid parameters in Percutaneous Coronary Intervention patients
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-09-28
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PCI Patients initiating statin therapy

Brief summary: Most PCI patients are at very high cardiovascular (CV) risk, and as such here is an increased need for intensive lipid management in Percutaneous Coronary Intervention (PCI) patients and the population is well suited to demonstrating rosuvastatin's low density lipoprotein-cholesterol (LDL-C) lowering efficacy.Most PCI patients are at very high CV risk, and as such here is an increased need for intensive lipid management in PCI patients and the population is well suited to demonstrating rosuvastatin's LDL-C lowering efficacy.The purpose of this study is to observe the effectiveness of statins on lipid level reduction (LDL-C, high density lipoprotein-cholesterol (HDL-C), Triglyceride (TG), and non-HDL-C) and lipid goal attainment according to recent guidelines.

Detailed description: The number of patients receiving Percutaneous Coronary Intervention (PCI) is rapidly increasing in China. In 2013, about 450,000 Chinese patients received PCI, most of whom suffered from coronary heart disease (CHD), especially acute coronary syndrome (ACS). ACS is associated with an increased risk of cardiovascular mortality and recurrent cardiac events, underscoring the importance of identifying treatments that minimize this risk.The Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) trial suggested a benefit of lipid lowering with high-dose atorvastatin in patients with ACS. A meta-analysis of statin use in patients with ACS confirmed the benefits of early high-dose statin administration in decreasing recurrent myocardial ischemia, which suggested the clinical benefit and safety of statins were dose and statin dependent. The updated National Cholesterol Education Program Adult Treatment Panel III guidelines recommend that intensive therapy should be considered for all patients admitted to hospital for an ACS. Two meta-analyses have shown that early intensive statin therapy in patients with ACS is associated with a reduced rate of death and cardiovascular events. In the PROVE IT study, comparing atorvastatin 80 mg with pravastatin 40 mg, a significant reduction in major adverse clinical events was observed in favour of more intensive statin treatment. In that study, the median concentration of low-density LDL-C was lowered from 106 mg/dL to 62 mg/dL in the atorvastatin 80 mg group. More recently, the 2011 European Society of Cardiology (ESC)/ European Arterial Sclerosis Association (EAS) guideline for the management of dyslipidemia recommended patients with ACS are very high CV risk patients and should achieve LDL-C level \<70 mg/dl or 50% reduction. In 2011 American College of Cardiology Foundation (ACCF) / American Heart Association (AHA) / (cardiovascular angiography and intervention Association)/ Association of Cardiovascular angiography and intervention (SCAI) Guideline for PCI, statin therapy which lowers LDL to \<70mg/dL in very high-risk patients is recommended (IIa, B). The latest China ACS consensus also recommends using the highest dose statin treatment for the acute phase and to attain an LDL-C level of 1.8 mmol/L or 50% reduction compared with baseline in long-term treatment. However, there are very limited Chinese data demonstrating the current situation of lipid management (LDL-C on-goal rate) by different statins in real-world clinical practice.

Most PCI patients are at very high CV risk, and as such here is an increased need for intensive lipid management in PCI patients and the population is well suited to demonstrating rosuvastatin's LDL-C lowering efficacy.Most PCI patients are at very high CV risk, and as such here is an increased need for intensive lipid management in PCI patients and the population is well suited to demonstrating rosuvastatin's LDL-C lowering efficacy.The purpose of this study is to observe the effectiveness of statins on lipid level reduction (LDL-C, HDL-C, TG, and non-HDL-C) and lipid goal attainment according to recent guidelines.

Eligibility criteria: Inclusion criteria:

* Patients must have had at least one treatment for statins, during the intake period (between 01/07/2011 and 31/01/2015). The date treated with statins after hospitalization before PCI or after PCI for statin naive patients, and date of PCI procedure for statin users will be marked as an index date.
* Patients must be 18 years or older at the time of index date.
* Patients must have at least 1 month of follow-up after the index date, including continuous statin treatment, lipid profile and lab values for safety profile.
* Patients must have at least two lab values: one full lipid panel prior to or on the index date, and one at least 30 days following the index date.

Exclusion criteria:

* Patients with a diagnosis of Familial Hypercholesterolemia.
* Patients with malignant tumor at the index day.

Primary outcomes:
measure: Change from baseline Low density lipoprotein-cholesterol (LDL-C) at 30 days
timeFrame: Blood samples are collected pre-dose, 30 days post dose
Secondary outcomes:
measure: Change from baseline lipid level at 30 days
timeFrame: Blood samples are collected pre-dose, 30 days post dose
measure: Change from baseline lipid level at 3 months
timeFrame: Blood samples are collected pre-dose, 3 months post dose
measure: Change from baseline lipid level at 6 months
timeFrame: Blood samples are collected pre-dose, 6 months post dose
measure: Change from baseline lipid level at 12 months
timeFrame: Blood samples are collected pre-dose, 12 months post dose
measure: number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 30 days
timeFrame: Blood samples are collected at 30 days post dose
measure: number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 3 months
timeFrame: Blood samples are collected at 3 months post dose
measure: number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 6 months
timeFrame: Blood samples are collected at 6 months post dose
measure: number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 12 months
timeFrame: Blood samples are collected at 12 months post dose
measure: Change from the baseline statin dose at 12 months
timeFrame: The dose of the treated statin is collected up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Chinese PLA General Hospital
name: Yundai Chen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: