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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01245738

Acronym

REMAINS

Enrollment

635

Registered

2010-11-22

Start date

2010-08-31

Completion date

2012-12-31

Last updated

2017-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Total Cholesterol (TC) Levels at First Acute Coronary Event	At hospital presentation (Day 1)	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).
Low-Density Lipoprotein Cholesterol (LDL-C) Levels at First Acute Coronary Event	At hospital presentation (Day 1)	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).
High-Density Lipoprotein Cholesterol (HDL-C) Levels at First Acute Coronary Event	At hospital presentation (Day 1)	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).
Triglycerides (TG) Levels at First Acute Coronary Event	At hospital presentation (Day 1)	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).
Change From Baseline in TC Levels After Treatment	Baseline and at Week 12	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.
Change From Baseline in LDL-C Levels After 12 Weeks of Treatment With Statins	Baseline and at Week 12	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.
Change From Baseline in HDL-C Levels After 12 Weeks of Treatment With Statins	Baseline and at Week 12	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.
Change From Baseline in TG Levels After 12 Weeks of Treatment With Statins	Baseline and at Week 12	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.
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	Week 12	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.
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	Week 12	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.
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	Week 12	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.
Percentage of Participants Who Did Not Achieve Target Lipid Levels for LDL-C, HDL-C, and TG After 12 Weeks of Treatment With Statins	Week 12	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.
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	Week 12	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.
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	Week 12	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.

Participant flow

Recruitment details

Data were collected at the time of the first acute coronary event and 12 weeks after post-event statin therapy among participants across 19 tertiary cardiac care centers in India.

Pre-assignment details

635 participants were considered eligible for the study, however; only 514 started (had complete baseline data).

Participants by arm

Arm	Count
Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.	474
Total	474

Baseline characteristics

Characteristic	Participants
Age, Continuous	54.2 Years STANDARD_DEVIATION 10.6
Sex: Female, Male Female	94 Participants
Sex: Female, Male Male	380 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 474
serious Total, serious adverse events	6 / 474

Outcome results

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.

Time frame: Baseline and at Week 12

Population: Participants of the FAS Population who had HDL-C measurements at baseline and Week 12.

Arm	Measure	Value (MEAN)	Dispersion
Participants	Change From Baseline in HDL-C Levels After 12 Weeks of Treatment With Statins	-1.2 mg/dL	Standard Deviation 18.01

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.

Time frame: Baseline and at Week 12

Population: Participants of the FAS Population who had LDL-C measurements at baseline and Week 12.

Arm	Measure	Value (MEAN)	Dispersion
Participants	Change From Baseline in LDL-C Levels After 12 Weeks of Treatment With Statins	-32.2 mg/dL	Standard Deviation 42.57

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.

Time frame: Baseline and at Week 12

Population: Participants of the Full Analysis Set (FAS) Population who had a TC measurements at baseline and Week 12.

Arm	Measure	Value (MEAN)	Dispersion
Participants	Change From Baseline in TC Levels After Treatment	-32.2 mg/dL	Standard Deviation 48.56

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.

Time frame: Baseline and at Week 12

Population: Participants of the FAS Population who had TG measurements at baseline and Week 12.

Arm	Measure	Value (MEAN)	Dispersion
Participants	Change From Baseline in TG Levels After 12 Weeks of Treatment With Statins	1.6 mg/dL	Standard Deviation 97.26

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).

Time frame: At hospital presentation (Day 1)

Population: Participants who had a HDL-C measurement at baseline.

Arm	Measure	Value (MEAN)	Dispersion
Participants	High-Density Lipoprotein Cholesterol (HDL-C) Levels at First Acute Coronary Event	42.9 mg/dL	Standard Deviation 17.23

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).

Time frame: At hospital presentation (Day 1)

Population: Participants who had a LDL-C measurement at baseline.

Arm	Measure	Value (MEAN)	Dispersion
Participants	Low-Density Lipoprotein Cholesterol (LDL-C) Levels at First Acute Coronary Event	105.9 mg/dL	Standard Deviation 37.55

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.

Time frame: Week 12

Population: Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements at Week 12.

Arm	Measure	Value (NUMBER)
Participants	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	11.6 Percentage of Participants

Primary