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Completed

NCT Number: NCT01245738

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

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).

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Key information

Conditions

Dyslipidemias High LDL-C Hypercholesterolemia Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Low HDL-C Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Acronym: REMAINS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 22, 2010
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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