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: May 3, 2013
Last verified: May 2013

August 13, 2010
May 3, 2013
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 ]
  • 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 ]
Same as current
Complete list of historical versions of study NCT01245738 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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 experiencing first acute cardiovascular event and the extent of residual dyslipidemia after 12 weeks of treatment with statins.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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
Drug: Statin
Any Statin Added or Adjusted by a Physician per Drug Label to Be Taken for at Least 12 Weeks
  • Taking Statin at Presentation
    These are subjects who were taking a statin at hospital presentation for their first acute coronary event.
    Intervention: Drug: Statin
  • Not Taking Statin at Presentation
    These are subjects who were not taking a statin at hospital presentation for their first acute coronary event.
    Intervention: Drug: Statin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
482
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:

  • Patients who are already participating in a clinical trial or any type of other clinical study involving therapeutic intervention or otherwise failing to consent to interview.
  • Patients with known inherited disorder of lipoprotein metabolism.
  • Patients with 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
Not Provided
 
NCT01245738
0000-204
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2013

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