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

Tracking Information
First Received Date ^ICMJE	August 13, 2010
Last Updated Date	May 3, 2013
Start Date ^ICMJE	August 2010
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 19, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01245738 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Statins on Lipid Levels Following the First Acute Coronary Event (MK-0000-204)
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition ^ICMJE	Dyslipidemias Hypercholesterolemia Hypertriglyceridemia High LDL-C Low HDL-C
Intervention ^ICMJE	Drug: Statin Any Statin Added or Adjusted by a Physician per Drug Label to Be Taken for at Least 12 Weeks
Study Group/Cohort (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	482
Completion Date	December 2012
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	35 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01245738
Other Study ID Numbers ^ICMJE	0000-204
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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