Effect of Statins on Lipid Levels Following the First Acute Coronary Event (MK-0000-204)

NCT ID: NCT01245738

Last Updated: 2017-03-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

635 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-12-31

Brief Summary

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The current study is proposed to investigate the pattern of dyslipidemia and of lipid treatment practices in patients in India experiencing their first acute cardiovascular event and the extent of residual dyslipidemia after 12 weeks of treatment with statins. Dyslipidemia definitions are per the National Cholesterol Education Program - Adult Treatment Panel III (NCEP-ATP III).

Detailed Description

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Conditions

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Dyslipidemias Hypercholesterolemia Hypertriglyceridemia High LDL-C Low HDL-C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants

Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Currently admitted with a confirmed diagnosis of first acute coronary event (STEMI/NSTEMI/Unstable Angina)
* Access to medical records covering the entire study period, and availability of data required for the study
* Potential to collect blood sample within 24 hours of onset for symptoms
* Considered for initiation/maintenance/modification of statin therapy before discharge from hospital
* Willing to comply with the study requirements

Exclusion Criteria

* Participating in a clinical trial or any type of other clinical study involving therapeutic intervention or otherwise failing to consent to interview
* Known inherited disorder of lipoprotein metabolism
* History of hypothyroidism, nephrotic syndrome, chronic alcoholism, Cushing syndrome
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Study Documents

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Document Type: CSR Synopsis

View Document

Other Identifiers

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CTRI/2013/02/003429

Identifier Type: REGISTRY

Identifier Source: secondary_id

0000-204

Identifier Type: -

Identifier Source: org_study_id

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