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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01245738
First received: August 13, 2010
Last updated: August 8, 2014
Last verified: August 2014

August 13, 2010
August 8, 2014
August 2010
December 2012   (final data collection date for primary outcome measure)
  • Total Cholesterol (TC) Levels at First Acute Coronary Event [ Time Frame: At hospital presentation (Day 1) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Total Cholesterol (TC) levels at First Acute Coronary Event [ Time Frame: At hospital presentation (Day 1) ] [ Designated as safety issue: No ]
  • Low-Density Lipoprotein Cholesterol (LDL-C) levels at First Acute Coronary Event [ Time Frame: At hospital presentation (Day 1) ] [ Designated as safety issue: No ]
  • High-Density Lipoprotein Cholesterol (HDL-C) levels at First Acute Coronary Event [ Time Frame: At hospital presentation (Day 1) ] [ Designated as safety issue: No ]
  • Triglyceride (TG) levels at First Acute Coronary Event [ Time Frame: At hospital presentation (Day 1) ] [ Designated as safety issue: No ]
  • Change in Total Cholesterol (TC) levels [ Time Frame: From Day 1 until after 12 weeks of treatment with statins ] [ Designated as safety issue: No ]
  • Change in Low-Density Lipoprotein Cholesterol (LDL-C) levels [ Time Frame: From Day 1 until after 12 weeks of treatment with statins ] [ Designated as safety issue: No ]
  • Change in High-Density Lipoprotein Cholesterol (HDL-C) levels [ Time Frame: From Day 1 until after 12 weeks of treatment with statins ] [ Designated as safety issue: No ]
  • Change in Triglyceride (TG) levels [ Time Frame: From Day 1 until after 12 weeks of treatment with statins ] [ Designated as safety issue: No ]
  • Proportion of Participants With HDL-C less than 40mg/dL, TG greater than 150mg/dL, and LDL-C less than 70 mg/dL [ Time Frame: After 12 Weeks of Treatment With Statins ] [ Designated as safety issue: No ]
  • Proportion of Participants With HDL-C less than 40mg/dL, TG less than 150mg/dL, and LDL-C less than 70 mg/dL [ Time Frame: After 12 Weeks of Treatment With Statins ] [ Designated as safety issue: No ]
  • Proportion of Participants With HDL-C greater than 40mg/dL, TG greater than 150mg/dL, and LDL-C less than 70 mg/dL [ Time Frame: After 12 Weeks of Treatment With Statins ] [ Designated as safety issue: No ]
  • Proportion of Participants With HDL-C less than 40mg/dL, TG greater than 150mg/dL, and LDL-C greater than 70 mg/dL [ Time Frame: After 12 Weeks of Treatment With Statins ] [ Designated as safety issue: No ]
  • Proportion of Participants With HDL-C less than 40mg/dL, TG less than 150mg/dL, and LDL-C greater than 70 mg/dL [ Time Frame: After 12 Weeks of Treatment With Statins ] [ Designated as safety issue: No ]
  • Proportion of Participants With HDL-C greater than 40mg/dL, TG greater than 150mg/dL, and LDL-C greater than 70 mg/dL [ Time Frame: After 12 Weeks of Treatment With Statins ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01245738 on ClinicalTrials.gov Archive Site
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Effect of Statins on Lipid Levels Following the First Acute Coronary Event (MK-0000-204)
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

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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Dyslipidemias
  • Hypercholesterolemia
  • Hypertriglyceridemia
  • High LDL-C
  • Low HDL-C
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Participants
Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
635
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01245738
0000-204, CTRI/2013/02/003429
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP