Dyslipidemia: REsidual and Mixed Abnormalities IN Spite of Statin Therapy: The Dyslipidemia REMAINS Study: A Multicenter, Prospective, Observational Study of Lipid Profiles and Treatment Patterns at Presentation and After 12 Weeks of Statin Therapy Among Indian Adults Presenting With First Coronary Event
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 635
- Primary Endpoint
- Total Cholesterol (TC) Levels at First Acute Coronary Event
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Total Cholesterol (TC) Levels at First Acute Coronary Event
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported