Text Size

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
ClinicalTrials.gov Identifier:
NCT01245738
First received: August 13, 2010
Last updated: May 3, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Dyslipidemias
Hypercholesterolemia
Hypertriglyceridemia
High LDL-C
Low HDL-C
 Drug: Statin

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:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ]

Enrollment: 482
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 Assigned Interventions
Taking Statin at Presentation
These are subjects who were taking a statin at hospital presentation for their first acute coronary event.
 Drug: Statin
Any Statin Added or Adjusted by a Physician per Drug Label to Be Taken for at Least 12 Weeks
Not Taking Statin at Presentation
These are subjects who were not taking a statin at hospital presentation for their first acute coronary event.
 Drug: Statin
Any Statin Added or Adjusted by a Physician per Drug Label to Be Taken for at Least 12 Weeks

  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:

  • 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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01245738     History of Changes
Other Study ID Numbers: 0000-204
Study First Received: August 13, 2010
Last Updated: May 3, 2013
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Hypercholesterolemia
Hypertriglyceridemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013