Effectiveness of Statins on Lipid Goal Attainment and Lipid Parameters in PCI Patients

Effectiveness of Statins on Lipid Goal Attainment and Lipid Parameters in Percutaneous Coronary Intervention Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: PCI Patients
• Intervention / Treatment: Drug: rosuvastatin

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

PCI Patients initiating statin therapy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
rosuvastatin group; patients who received rosuvastatin	Drug: rosuvastatin; 5mg, 10mg, 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Low density lipoprotein-cholesterol (LDL-C) at 30 days	by assessment of statins on the on-goal rate of LDL-C treatment of patients underwent PCI	Blood samples are collected pre-dose, 30 days post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline lipid level at 30 days	by assessment of other lipid level reduction from baseline lab value to the last lab value	Blood samples are collected pre-dose, 30 days post dose
Change from baseline lipid level at 3 months	by assessment of other lipid level reduction from baseline lab value to the last lab value	Blood samples are collected pre-dose, 3 months post dose
Change from baseline lipid level at 6 months	by assessment of other lipid level reduction from baseline lab value to the last lab value	Blood samples are collected pre-dose, 6 months post dose
Change from baseline lipid level at 12 months	by assessment of other lipid level reduction from baseline lab value to the last lab value	Blood samples are collected pre-dose, 12 months post dose
number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 30 days	by assessment of safety profile	Blood samples are collected at 30 days post dose
number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 3 months	by assessment of safety profile	Blood samples are collected at 3 months post dose
number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 6 months	by assessment of safety profile	Blood samples are collected at 6 months post dose
number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 12 months	by assessment of safety profile	Blood samples are collected at 12 months post dose
Change from the baseline statin dose at 12 months	by assessment of treatment patterns and adherence of the index statin therapy	The dose of the treated statin is collected up to 12 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Yundai Chen, MD,PhD, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: September 16, 2015
• First Submitted That Met QC Criteria: September 25, 2015
• First Posted (Estimate): September 28, 2015

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Effectiveness of statins, on lipid goal attainment and lipid parameters in Percutaneous Coronary Intervention patients
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: D3560R00019