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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)

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: January 11, 2010
Last updated: February 29, 2012
Last verified: February 2012
To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.

Coronary Heart Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Prospective Study to esTIMAte the Rates of Outcomes in Patients Undergoing PCI With Drug Eluting Stent (DES) Implantation Who Take Statins

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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 ]
  • 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. [ Time Frame: 3 visits for 12 months ]
  • To estimate inflammatory markers (C-reactive protein (CRP) and Leukocytes) in patients prior and after PCI. [ Time Frame: 3 visits for 12 months ]
  • To estimate cardiac markers (Troponin I, brain natriuretic peptide (BNP)) in patients before PCI. [ Time Frame: 3 visits for 12 months ]
  • To study lipoprotein associated phospholipase A2 (Lp PLA2) in patients before PCI and its' association with PCI outcome. [ Time Frame: 3 visits for 12 months ]
  • To study the rate of early and late stent thrombosis according to ARC classification [ Time Frame: 3 visits for 12 months ]

Enrollment: 602
Study Start Date: December 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Male or female > 18 year of age with indication to PCI


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital patient

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01047176

Russian Federation
Research Site
Moscow, Russian Federation
Sponsors and Collaborators
Principal Investigator: Yuri A Karpov RCRC (РКНПК)
  More Information

Responsible Party: AstraZeneca Identifier: NCT01047176     History of Changes
Other Study ID Numbers: NIS-CRU-CRE-2009/1
Study First Received: January 11, 2010
Last Updated: February 29, 2012

Keywords provided by AstraZeneca:
Coronary Heart Disease
Percutaneous coronary intervention (PCI)

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arterial Occlusive Diseases processed this record on April 26, 2017