Text Size

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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01047176
First received: January 11, 2010
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  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:

U.S. FDA Resources

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) ] [ Designated as safety issue: No ]

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 ] [ 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. [ Time Frame: 3 visits for 12 months ] [ Designated as safety issue: No ]
  • To estimate inflammatory markers (C-reactive protein (CRP) and Leukocytes) in patients prior and after PCI. [ Time Frame: 3 visits for 12 months ] [ Designated as safety issue: No ]
  • To estimate cardiac markers (Troponin I, brain natriuretic peptide (BNP)) in patients before PCI. [ Time Frame: 3 visits for 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To study the rate of early and late stent thrombosis according to ARC classification [ Time Frame: 3 visits for 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047176

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov 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
Health Authority: Russia: Ethics Committee

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Dyslipidemias
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 13, 2013