Clinical trial NCT01047176: Observational Study to Estimate the Rates of Outcomes in Patients Undergoing Percutaneous Coronary Intervention (PCI) With Drug Eluting Stent (DES) Implantation Who Take Statins
Official title: Observational Prospective Study to esTIMAte the Rates of Outcomes in Patients Undergoing PCI With Drug Eluting Stent (DES) Implantation Who Take Statins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Coronary Heart Disease
Keywords: Statins
Coronary Heart Disease
Percutaneous coronary intervention (PCI)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-01-12
Enrollment: 602
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital patient

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


Eligibility criteria: 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

Primary outcomes:
measure: To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.
timeFrame: 3 visits for 12 month (before and after PCI)
Secondary outcomes:
measure: 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
timeFrame: 3 visits for 12 month
measure: 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.
timeFrame: 3 visits for 12 months
measure: To estimate inflammatory markers (C-reactive protein (CRP) and Leukocytes) in patients prior and after PCI.
timeFrame: 3 visits for 12 months
measure: To estimate cardiac markers (Troponin I, brain natriuretic peptide (BNP)) in patients before PCI.
timeFrame: 3 visits for 12 months
measure: To study lipoprotein associated phospholipase A2 (Lp PLA2) in patients before PCI and its' association with PCI outcome.
timeFrame: 3 visits for 12 months
measure: To study the rate of early and late stent thrombosis according to ARC classification
timeFrame: 3 visits for 12 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Research Site
Study officials:
affiliation: RCRC (РКНПК)
name: Yuri A Karpov
role: PRINCIPAL_INVESTIGATOR
References: