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
  Purpose

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).


Condition
Dyslipidemias
Hypercholesterolemia
Hypertriglyceridemia
High LDL-C
Low HDL-C

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.


Enrollment: 635
Study Start Date: August 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Participants
Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01245738     History of Changes
Other Study ID Numbers: 0000-204, CTRI/2013/02/003429
Study First Received: August 13, 2010
Results First Received: August 8, 2014
Last Updated: August 8, 2014
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Hypercholesterolemia
Hypertriglyceridemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 27, 2014