Observational Prospective Study to esTIMAte the Rates of Outcomes in Patients Undergoing PCI With Drug Eluting Stent (DES) Implantation Who Take Statins

AstraZeneca1 site in 1 country602 target enrollmentDecember 2009

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dyslipidemia
Sponsor: AstraZeneca
Enrollment: 602
Locations: 1
Primary Endpoint: To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.
Status: Completed
Last Updated: 14 years ago

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

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

December 2011

Last Updated

14 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•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.

•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

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

Time Frame: 3 visits for 12 month (before and after PCI)

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)