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

NCT02561845 | Withdrawn

• 1 other identifier: D3560R00019
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PCI Patients

Keywords

Effectiveness of statins, on lipid goal attainment and lipid parameters in Percutaneous Coronary Intervention patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change from baseline lipid level at 30 days

  Blood samples are collected pre-dose, 30 days post dose

• Change from baseline lipid level at 3 months

  Blood samples are collected pre-dose, 3 months post dose

• Change from baseline lipid level at 6 months

  Blood samples are collected pre-dose, 6 months post dose

• Change from baseline lipid level at 12 months

  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

  Blood samples are collected at 30 days post dose

Study Arms (1)

rosuvastatin group

patients who received rosuvastatin

Drug: rosuvastatin

Interventions

rosuvastatin DRUG

5mg, 10mg, 20mg

rosuvastatin group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

PCI Patients initiating statin therapy

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yundai Chen, MD,PhD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 28, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 11, 2016

Record last verified: 2016-04