Observational Study to Estimate the Rates of Outcomes in Patients Undergoing Percutaneous Coronary Intervention (PCI) With Drug Eluting Stent (DES) Implantation Who Take Statins

Completed

• Conditions: Dyslipidemia; Coronary Heart Disease

• Registration Number: NCT01047176
• Lead Sponsor: AstraZeneca

Brief Summary

To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-29
• Last Update Posted: 2012-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 602

Inclusion Criteria

• Stable angina with indication to PCI
• Hospitalization to Russian Cardiological Research Center (РКНПК) for PCI procedure with drug-eluting stents implantation
• Statin therapy initiated for at least one month prior to PCI
• Written informed consent provided prior the start of participation in the study.

Exclusion Criteria

• Subjects who are unwilling or unable to provide informed consent.
• Presence of ACS during the current hospitalization
• Severe CHF (NYHA III/IV) or LVEF<40 %
• Stroke within 6 months before PCI
• Acute or chronic inflammatory disease
• Anti-inflammatory medications intake, with the exception of aspirin
• Severe liver or muscle disease
• Severe kidney disease / renal failure with creatinine > 3 mg/dl
• History of oncologic disease
• Conceivable impossibility to come in touch with the patient or his family at 1-year after the intervention

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.	3 visits for 12 month (before and after PCI)

Secondary Outcome Measures

Name	Time	Method
To evaluate prognostic factors (demographic, co-morbidity, smoking, LDL-C, inflammatory and cardiac markers) in patients undergoing PCI with drug eluting stent (DES) implantation who take statins and their association with PCI (MACCE) outcomes	3 visits for 12 month
To estimate Low Density Lipoprotein Cholesterol (LDL-C) target level achievement and lipid-lowering therapy details in patients taking standard lipid lowering therapy prior the PCI.	3 visits for 12 months
To estimate inflammatory markers (C-reactive protein (CRP) and Leukocytes) in patients prior and after PCI.	3 visits for 12 months
To estimate cardiac markers (Troponin I, brain natriuretic peptide (BNP)) in patients before PCI.	3 visits for 12 months
To study lipoprotein associated phospholipase A2 (Lp PLA2) in patients before PCI and its' association with PCI outcome.	3 visits for 12 months
To study the rate of early and late stent thrombosis according to ARC classification	3 visits for 12 months

Trial Locations

Locations (1)

Research Site; 🇷🇺 Moscow, Russian Federation