N/A
N=514
Effect of Statins on Lipid Levels Following the First Acute Coronary Event (MK-0000-204)
Dyslipidemias · Hypercholesterolemia · Hypertriglyceridemia · High LDL-C · Low HDL-C
Bottom Line
View on ClinicalTrials.gov: NCT01245738 ↗Enrolled (actual)
514
Serious AEs
1.3%
Results posted
Aug 2014
Primary outcome: Primary: Total Cholesterol (TC) Levels at First Acute Coronary Event — 163.5 mg/dL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Cholesterol (TC) Levels at First Acute Coronary Event |
163.5 | — |
| PRIMARY Low-Density Lipoprotein Cholesterol (LDL-C) Levels at First Acute Coronary Event |
105.9 | — |
| PRIMARY High-Density Lipoprotein Cholesterol (HDL-C) Levels at First Acute Coronary Event |
42.9 | — |
| PRIMARY Triglycerides (TG) Levels at First Acute Coronary Event |
146.9 | — |
| PRIMARY Change From Baseline in TC Levels After Treatment |
-32.2 | — |
| PRIMARY Change From Baseline in LDL-C Levels After 12 Weeks of Treatment With Statins |
-32.2 | — |
| PRIMARY Change From Baseline in HDL-C Levels After 12 Weeks of Treatment With Statins |
-1.2 | — |
| PRIMARY Change From Baseline in TG Levels After 12 Weeks of Treatment With Statins |
1.6 | — |
| PRIMARY 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 |
11.6 | — |
| PRIMARY 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 |
54.4 | — |
| PRIMARY 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 |
17.1 | — |
| PRIMARY Percentage of Participants Who Did Not Achieve Target Lipid Levels for LDL-C, HDL-C, and TG After 12 Weeks of Treatment With Statins |
1.1 | — |
| PRIMARY 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 |
1.3 | — |
| PRIMARY 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 |
0.6 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01245738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.