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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01047176
First Posted: January 12, 2010
Last Update Posted: March 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.

Condition
Dyslipidemia 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)
Groups/Cohorts
1
Male or female > 18 year of age with indication to PCI

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047176


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01047176     History of Changes
Other Study ID Numbers: NIS-CRU-CRE-2009/1
First Submitted: January 11, 2010
First Posted: January 12, 2010
Last Update Posted: March 1, 2012
Last Verified: February 2012

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

Additional relevant MeSH terms:
Heart Diseases
Dyslipidemias
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents