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Completed

NCT Number: 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

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

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Key information

Conditions

Dyslipidemia Cardiovascular Diseases Coronary Disease Coronary Heart Disease Dyslipidemias Heart Diseases Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Moscow, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. To estimate inflammatory markers (C-reactive protein (CRP) and Leukocytes) in patients prior and after PCI.

    Time frame: 3 visits for 12 months

  4. To estimate cardiac markers (Troponin I, brain natriuretic peptide (BNP)) in patients before PCI.

    Time frame: 3 visits for 12 months

  5. 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

  6. To study the rate of early and late stent thrombosis according to ARC classification

    Time frame: 3 visits for 12 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: OPTIMA

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 12, 2010
Registry last updated
Mar 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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