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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00993915
First received: October 13, 2009
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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 Intervention
Cardiovascular Diseases
Coronary Artery Disease
Drug: Atorvastatin

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Achieving LDL Level Less Than or Equal to (≤) 100 mg/dL at the 6 Month Visit [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]

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

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


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

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


Enrollment: 687
Study Start Date: April 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993915

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00993915     History of Changes
Other Study ID Numbers: A2581185
Study First Received: October 13, 2009
Results First Received: November 21, 2012
Last Updated: January 7, 2013
Health Authority: Russia: National Ethics Committee

Keywords provided by Pfizer:
Coronary Artery Disease
Hyperlipidemia
Atorvastatin

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014