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

Hypercholesterolemia Clinical Trial

— REMAINS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245738
• Other study ID #: 0000-204
• Secondary ID: CTRI/2013/02/003
• Status: Completed
• Phase: N/A
• First received: August 13, 2010
• Last updated: August 12, 2015
• Start date: August 2010
• Est. completion date: December 2012

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 635
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Cholesterol (TC) Levels at First Acute Coronary Event	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).	At hospital presentation (Day 1)	No
Primary	Low-Density Lipoprotein Cholesterol (LDL-C) Levels at First Acute Coronary Event	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).	At hospital presentation (Day 1)	No
Primary	High-Density Lipoprotein Cholesterol (HDL-C) Levels at First Acute Coronary Event	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).	At hospital presentation (Day 1)	No
Primary	Triglycerides (TG) Levels at First Acute Coronary Event	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).	At hospital presentation (Day 1)	No
Primary	Change From Baseline in TC Levels After Treatment	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.	Baseline and at Week 12	No
Primary	Change From Baseline in LDL-C Levels After 12 Weeks of Treatment With Statins	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.	Baseline and at Week 12	No
Primary	Change From Baseline in HDL-C Levels After 12 Weeks of Treatment With Statins	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.	Baseline and at Week 12	No
Primary	Change From Baseline in TG Levels After 12 Weeks of Treatment With Statins	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.	Baseline and at Week 12	No
Primary	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	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.	Week 12	No
Primary	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	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.	Week 12	No
Primary	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	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.	Week 12	No
Primary	Percentage of Participants Who Did Not Achieve Target Lipid Levels for LDL-C, HDL-C, and TG After 12 Weeks of Treatment With Statins	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.	Week 12	No
Primary	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	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.	Week 12	No
Primary	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	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.	Week 12	No