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Study On Liprimar (Atorvastatin) In Patients With Coronary Heart Disease (CHD) And High Risk Of Cardiovascular Complications (LIGHT)

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ClinicalTrials.gov Identifier: NCT00993915
Recruitment Status : Completed
First Posted : October 14, 2009
Results First Posted : December 20, 2012
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description
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Brief Summary:
In which CHD patients with high risk of CV complications are different doses of LIPRIMAR used? For this purpose, data on hyperlipidemia will be elicited over and above the basic nosographic and demographic data, concomitant diseases and cardiovascular risk factor.

Condition or disease Intervention/treatment
Cardiovascular Diseases Coronary Artery Disease Drug: Atorvastatin

Study Design
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Study Type : Observational
Actual Enrollment : 687 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non Interventional (NI) Open Label Prospective Study On Liprimar (Atorvastatin) In Patients With Coronary Heart Disease (CHD) And High Risk Of Cardiovascular Complications
Study Start Date : April 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Main group
Newly diagnosed or known coronary artery disease and known dislipidemia and high risk of cardiovascular complications
 Drug: Atorvastatin
Atorvastatin, 10- 80 mg, once daily, 6 month treatment


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving LDL Level Less Than or Equal to (≤) 100 mg/dL at the 6 Month Visit [ Time Frame: Month 6 ]

Secondary Outcome Measures :
  1. Percentage of Participants Achieving LDL Level ≤ 100 mg/dL at the 1 Month Visit [ Time Frame: Month 1 ]
  2. Change From Baseline in Lipid Parameters [ Time Frame: Month 6 ]
    Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline

  3. Percent Change From Baseline in Lipid Parameters [ Time Frame: Month 6 ]
    Percent change from baseline calculated as: 100*(change at Month X)/(baseline value).


Other Outcome Measures:
  1. Change From Baseline in Lipid Parameters at 1 Month [ Time Frame: Month 1 ]
    Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline

  2. Percent Change From Baseline in Lipid Parameters at 1 Month [ Time Frame: Month 1 ]
    Percent change from baseline calculated as: 100*(change at Month X)/(baseline value).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Coronary atery disease, prevention of high risk cardiovascular complications with statins.
Criteria

Inclusion Criteria:

  • Patients, who eligible to sign informed consent;
  • Patients with indications to lipid lowing therapy, according to local product document.
  • Patients with CHD and high risk of CV complications (Diabetes Mellitus II, Myocardial Infarction, Heart Failure, Arterial Hypertension, ets) will be included into study;
  • Patients with LDL levels: > 3,5 mmol/l

Exclusion Criteria:

  • Individual intolerance of atorvastatin, in accordance to local product document.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993915


Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00993915    
Other Study ID Numbers: A2581185
First Posted: October 14, 2009    Key Record Dates
Results First Posted: December 20, 2012
Last Update Posted: February 18, 2021
Last Verified: February 2021
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
Coronary Artery Disease
Hyperlipidemia
Atorvastatin
Additional relevant MeSH terms:
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Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors