Trial Outcomes & Findings for Effect of Statins on Lipid Levels Following the First Acute Coronary Event (MK-0000-204) (NCT NCT01245738)

NCT ID: NCT01245738

Last Updated: 2017-03-10

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 635 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2017-03-10

Participant Flow

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.

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

Participant milestones

Measure	Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
Overall Study STARTED	514
Overall Study COMPLETED	474
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Participants n=474 Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
Age, Continuous	54.2 Years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants
Sex: Female, Male Male	380 Participants n=5 Participants

PRIMARY outcome

Timeframe: At hospital presentation (Day 1)

Population: Participants who had a total cholesterol measurement at baseline.

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).

Outcome measures

Measure	Participants n=474 Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
Total Cholesterol (TC) Levels at First Acute Coronary Event	163.5 mg/dL Standard Deviation 42.16

PRIMARY outcome

Timeframe: At hospital presentation (Day 1)

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

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).

Outcome measures

Measure	Participants n=472 Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
Low-Density Lipoprotein Cholesterol (LDL-C) Levels at First Acute Coronary Event	105.9 mg/dL Standard Deviation 37.55

PRIMARY outcome

Timeframe: At hospital presentation (Day 1)

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

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).

Outcome measures

Measure	Participants n=474 Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
High-Density Lipoprotein Cholesterol (HDL-C) Levels at First Acute Coronary Event	42.9 mg/dL Standard Deviation 17.23

PRIMARY outcome

Timeframe: At hospital presentation (Day 1)

Population: Participants who had a TG measurement at baseline.

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).

Outcome measures

Measure	Participants n=474 Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
Triglycerides (TG) Levels at First Acute Coronary Event	146.9 mg/dL Standard Deviation 97.65

PRIMARY outcome

Timeframe: Baseline and at Week 12

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

Outcome measures

Measure	Participants n=471 Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
Change From Baseline in TC Levels After Treatment	-32.2 mg/dL Standard Deviation 48.56

PRIMARY outcome

Timeframe: Baseline and at Week 12

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

Outcome measures

Measure	Participants n=468 Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
Change From Baseline in LDL-C Levels After 12 Weeks of Treatment With Statins	-32.2 mg/dL Standard Deviation 42.57

PRIMARY outcome

Timeframe: Baseline and at Week 12

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

Outcome measures

Measure	Participants n=471 Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
Change From Baseline in HDL-C Levels After 12 Weeks of Treatment With Statins	-1.2 mg/dL Standard Deviation 18.01

PRIMARY outcome

Timeframe: Baseline and at Week 12

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

Outcome measures

Measure	Participants n=471 Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
Change From Baseline in TG Levels After 12 Weeks of Treatment With Statins	1.6 mg/dL Standard Deviation 97.26

PRIMARY outcome

Timeframe: Week 12

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

Outcome measures

Measure	Participants n=474 Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
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 outcome

Timeframe: Week 12

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

Outcome measures

Measure	Participants n=474 Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
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	54.4 Percentage of Participants

PRIMARY outcome

Timeframe: Week 12

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

Outcome measures

Measure	Participants n=474 Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
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	17.1 Percentage of Participants

PRIMARY outcome

Timeframe: Week 12

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

Outcome measures

Measure	Participants n=474 Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
Percentage of Participants Who Did Not Achieve Target Lipid Levels for LDL-C, HDL-C, and TG After 12 Weeks of Treatment With Statins	1.1 Percentage of Participants

PRIMARY outcome

Timeframe: Week 12

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

Outcome measures

Measure	Participants n=474 Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
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	1.3 Percentage of Participants

PRIMARY outcome

Timeframe: Week 12

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

Outcome measures

Measure	Participants n=474 Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
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	0.6 Percentage of Participants

Adverse Events

Participants

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Participants n=474 participants at risk Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
Cardiac disorders Coronary artery disease	0.21% 1/474 • Number of events 1 • Up to 12 Weeks
Cardiac disorders Myocardial Infarction	0.84% 4/474 • Number of events 4 • Up to 12 Weeks
Infections and infestations Gastroenteritis	0.21% 1/474 • Number of events 1 • Up to 12 Weeks
Nervous system disorders Sensory Disturbance	0.21% 1/474 • Number of events 1 • Up to 12 Weeks

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The scientific information generated from this study will be publically disclosed in forms of peer reviewed publication and scientific presentations and may even be actively disseminated amongst the practicing medical community in appropriate scientific platforms.
• Publication restrictions are in place

Restriction type: OTHER