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


Tracking Information

Start Date  ICMJENovember 2009
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: January 11, 2010)		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) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT01047176 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: January 11, 2010)
  • 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 [ Time Frame: 3 visits for 12 month ] [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: No ]
  • To estimate inflammatory markers (C-reactive protein (CRP) and Leukocytes) in patients prior and after PCI. [ Designated as safety issue: No ]
  • To estimate cardiac markers (Troponin I, brain natriuretic peptide (BNP)) in patients before PCI. [ Designated as safety issue: No ]
  • To study lipoprotein associated phospholipase A2 (Lp PLA2) in patients before PCI and its' association with PCI outcome. [ Designated as safety issue: No ]
  • To study the rate of early and late stent thrombosis according to ARC classification [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

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

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

Detailed Description 
Study Phase 
Study Type  ICMJEObservational
Study Design  ICMJECase-Only, Prospective
Condition  ICMJE
  • Dyslipidemia
  • Coronary Heart Disease
Intervention  ICMJE 
Study Arms / Comparison Groups1
Male or female > 18 year of age with indication to PCI

Recruitment Information

Estimated Enrollment  ICMJE1000
Completion Date 
Primary Completion Date 
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: AstraZeneca Russia Clinical Study Information007-495-799-56-99Evgeniya.Zorina@AstraZeneca.com

Administrative Information

NCT ID  ICMJENCT01047176
Responsible PartyEvgeniya Zorina, Medical Advisor, AstraZeneca, Russia
Study ID Numbers  ICMJENIS-CRU-CRE-2009/1
Study Sponsor  ICMJEAstraZeneca
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:Yuri A KarpovRCRC (РКНПК)
Information Provided ByAstraZeneca

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