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

Completed

• Conditions: High LDL-C; Dyslipidemias; Hypercholesterolemia; Low HDL-C; Hypertriglyceridemia

• Registration Number: NCT01245738
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-13
• Study First Submitted QC: 2010-11-19
• Study First Posted: 2010-11-22
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2014-08-08
• Results First Submitted QC: 2014-08-08
• Results First Posted: 2014-08-22
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 635

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Cholesterol (TC) Levels at First Acute Coronary Event	At hospital presentation (Day 1)	At the time of hospital admission for a first acute coronary event, the TC levels of eligible participants were taken. This level was considered the baseline value. A TC level of \>240 mg/dL is considered an abnormal lipid value (dyslipidemia).
Low-Density Lipoprotein Cholesterol (LDL-C) Levels at First Acute Coronary Event	At hospital presentation (Day 1)	At the time of hospital admission for a first acute coronary event, the LDL-C levels of eligible participants were taken. This level was considered the baseline value. A LDL-C level of \>70 mg/dL is considered an abnormal lipid value (dyslipidemia).
High-Density Lipoprotein Cholesterol (HDL-C) Levels at First Acute Coronary Event	At hospital presentation (Day 1)	At the time of hospital admission for a first acute coronary event, the HDL-C levels of eligible participants were taken. This level was considered the baseline value. A HDL-C level of \<40 mg/dL is considered an abnormal lipid value (dyslipidemia).
Triglycerides (TG) Levels at First Acute Coronary Event	At hospital presentation (Day 1)	At the time of hospital admission for a first acute coronary event, the TG levels of eligible participants were taken. This level was considered the baseline value. A TG level of \>150 mg/dL is considered an abnormal lipid value (dyslipidemia).
Change From Baseline in TC Levels After Treatment	Baseline and at Week 12	TC levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.
Change From Baseline in LDL-C Levels After 12 Weeks of Treatment With Statins	Baseline and at Week 12	LDL-C levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.
Change From Baseline in HDL-C Levels After 12 Weeks of Treatment With Statins	Baseline and at Week 12	HDL-C levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.
Change From Baseline in TG Levels After 12 Weeks of Treatment With Statins	Baseline and at Week 12	TG levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between Baseline and Week 12 values.
Percentage of Participants Who Achieved Target Lipid Levels for LDL-C But Did Not Achieve Target Lipid Levels for HDL-C and TG After 12 Weeks of Treatment With Statins	Week 12	The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
Percentage of Participants Who Achieved Target Lipid Levels for TG and LDL-C But Did Not Achieve Target Lipid Levels for HDL-C After 12 Weeks of Treatment With Statins	Week 12	The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
Percentage of Participants Who Achieved Target Lipid Levels of HDL-C and LDL-C But Did Not Achieve Target Lipid Levels for TG After 12 Weeks of Treatment With Statins	Week 12	The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
Percentage of Participants Who Did Not Achieve Target Lipid Levels for LDL-C, HDL-C, and TG After 12 Weeks of Treatment With Statins	Week 12	The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
Percentage of Participants Who Achieved Target Lipid Levels for TG But Did Not Achieve Target Lipid Levels for HDL-C and LDL-C After 12 Weeks of Treatment With Statins	Week 12	The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
Percentage of Participants Who Achieved Target Lipid Levels of HDL-C But Did Not Achieve Target Lipid Levels for TG and LDL-C After 12 Weeks of Treatment With Statins	Week 12	The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.