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)

AstraZeneca

Status: Completed

Conditions: Coronary Heart Disease; Dyslipidemia

Study type: Observational

Funder types: Industry

Identifiers

NCT01047176

NIS-CRU-CRE-2009/1

Details and patient eligibility

About

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

Enrollment: 602 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

602 participants in 1 patient group

1

Description:

Male or female \> 18 year of age with indication to PCI