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

NCT01245738 | Completed Results

• 2 other identifiers: 0000-204CTRI/2013/02/003429
• Study Type: observational
• Target: 635
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

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

Outcome Measures

Primary Outcomes (14)

• 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)

• 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)

• 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)

• 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)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Participants

Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Dyslipidemias; Hypercholesterolemia; Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: November 22, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 10, 2017
• Results First Posted: August 22, 2014

Record last verified: 2017-01