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

NCT ID: NCT01047176

Last Updated: 2012-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

602 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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Conditions

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Dyslipidemia Coronary Heart Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuri A Karpov

Role: PRINCIPAL_INVESTIGATOR

RCRC (РКНПК)

Locations

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Research Site

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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NIS-CRU-CRE-2009/1

Identifier Type: -

Identifier Source: org_study_id

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