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

Coronary Heart Disease Clinical Trial

— OPTIMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047176
• Other study ID #: NIS-CRU-CRE-2009/1
• Status: Completed
• Phase: N/A
• First received: January 11, 2010
• Last updated: February 29, 2012
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stable angina with indication to PCI

• Hospitalization to Russian Cardiological Research Center (?????) 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Dyslipidemia
• Dyslipidemias
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
Russian Federation	Research Site	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.		3 visits for 12 month (before and after PCI)	No
Secondary	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		3 visits for 12 month	No
Secondary	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.		3 visits for 12 months	No
Secondary	To estimate inflammatory markers (C-reactive protein (CRP) and Leukocytes) in patients prior and after PCI.		3 visits for 12 months	No
Secondary	To estimate cardiac markers (Troponin I, brain natriuretic peptide (BNP)) in patients before PCI.		3 visits for 12 months	No
Secondary	To study lipoprotein associated phospholipase A2 (Lp PLA2) in patients before PCI and its' association with PCI outcome.		3 visits for 12 months	No
Secondary	To study the rate of early and late stent thrombosis according to ARC classification		3 visits for 12 months	No