Clinical trial NCT01245738: Effect of Statins on Lipid Levels Following the First Acute Coronary Event (MK-0000-204)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemias
Hypercholesterolemia
Hypertriglyceridemia
High LDL-C
Low HDL-C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-11-22
Enrollment: 635
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients experiencing their first acute coronary event who are admitted to participating tertiary cardiac care centers in India will potentially be eligible for the study.

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).


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

Primary outcomes:
measure: Total Cholesterol (TC) Levels at First Acute Coronary Event
timeFrame: At hospital presentation (Day 1)
measure: Low-Density Lipoprotein Cholesterol (LDL-C) Levels at First Acute Coronary Event
timeFrame: At hospital presentation (Day 1)
measure: High-Density Lipoprotein Cholesterol (HDL-C) Levels at First Acute Coronary Event
timeFrame: At hospital presentation (Day 1)
measure: Triglycerides (TG) Levels at First Acute Coronary Event
timeFrame: At hospital presentation (Day 1)
measure: Change From Baseline in TC Levels After Treatment
timeFrame: Baseline and at Week 12
measure: Change From Baseline in LDL-C Levels After 12 Weeks of Treatment With Statins
timeFrame: Baseline and at Week 12
measure: Change From Baseline in HDL-C Levels After 12 Weeks of Treatment With Statins
timeFrame: Baseline and at Week 12
measure: Change From Baseline in TG Levels After 12 Weeks of Treatment With Statins
timeFrame: Baseline and at Week 12
measure: 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
timeFrame: Week 12
measure: 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
timeFrame: Week 12
measure: 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
timeFrame: Week 12
measure: Percentage of Participants Who Did Not Achieve Target Lipid Levels for LDL-C, HDL-C, and TG After 12 Weeks of Treatment With Statins
timeFrame: Week 12
measure: 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
timeFrame: Week 12
measure: 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
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: