NCT00723723

Brief Summary

This observational study is being conducted in patients receiving statin treatment as secondary prevention of coronary heart disease under the current standard of care in compliance with European guidelines. The purpose of the study is to evaluate the percentage of these patients that reach target LDL levels. Additionally this study will measure the patient's compliance to treatment as assessed by counting the returned tablets. Both assessments will be made at visits conducted 6-8 weeks after the first visit and 28-32 weeks after the first visit.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
555

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

1.4 years

First QC Date

July 25, 2008

Last Update Submit

February 7, 2022

Conditions

Coronary Heart DiseaseHypercholesterolemiaHyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • percentage of patients reaching target LDL levels

    6-8 weeks after first visit and 28-32 weeks after first visit

Secondary Outcomes (1)

  • measure patient compliance to treatment as assessed by counting returned tablets

    6-8 weeks after first visit and 28-32 weeks after first visit

Study Arms (1)

Patients with coronary heart disease

Patients being treated with a statin for secondary prevention of coronary heart disease

Drug: Statin

Interventions

StatinDRUG

Statin

Patients with coronary heart disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients being treated with a statin for secondary prevention of coronary heart disease

You may qualify if:

  • willingness to participate in the study
  • years of age or more
  • clinically established cardiovascular disease to be considered as patients in secondary prevention
  • prior therapy with any statin without achieving goal (2.5 mmol/L of LDL cholesterol) at last lipid check performed

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary DiseaseHypercholesterolemiaHyperlipidemias

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEnzyme InhibitorsLipid Regulating AgentsTherapeutic Uses

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2008

First Posted

July 29, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 16, 2022

Record last verified: 2022-02