Trial Outcomes & Findings for Alirocumab in Patients With Acute Myocardial Infarction (NCT NCT02938949)

NCT ID: NCT02938949

Last Updated: 2019-09-06

Results Overview

Placebo-corrected percentage change in calculated LDL cholesterol from baseline to day 14

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: baseline and 14 days
• Results posted on: 2019-09-06

Participant Flow

Participant milestones

Measure	Alirocumab Alirocumab (150 mg) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin. alirocumab	Placebo Placebo (sterile saline) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin. placebo
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alirocumab in Patients With Acute Myocardial Infarction

Baseline characteristics by cohort

Measure	Alirocumab n=10 Participants Alirocumab (150 mg) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin. alirocumab	Placebo n=10 Participants Placebo (sterile saline) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin. placebo	Total n=20 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	56 years n=7 Participants	59 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
body mass index	27.8 kilograms per meters squared n=5 Participants	31.9 kilograms per meters squared n=7 Participants	30.9 kilograms per meters squared n=5 Participants

PRIMARY outcome

Timeframe: baseline and 14 days

Placebo-corrected percentage change in calculated LDL cholesterol from baseline to day 14

Outcome measures

Measure	Alirocumab n=10 Participants Alirocumab (150 mg) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin. alirocumab	Placebo n=10 Participants Placebo (sterile saline) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin. placebo
Changes in Low-density Lipoprotein (LDL) Cholesterol	-73 percent change Interval -83.0 to -56.0	2 percent change Interval -12.0 to 11.0

SECONDARY outcome

Timeframe: baseline to 3 days

Population: Research team was unable to collect samples from 2 Alirocumab participants.

Placebo-corrected percentage change in inflammatory markers (hsCRP) from baseline to 3 days

Outcome measures

Measure	Alirocumab n=8 Participants Alirocumab (150 mg) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin. alirocumab	Placebo n=10 Participants Placebo (sterile saline) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin. placebo
Change in Inflammatory Markers (hsCRP)	58 percent change Interval -27.0 to 82.0	55 percent change Interval -25.0 to 161.0

SECONDARY outcome

Timeframe: baseline to 14 days

Placebo-corrected Percentage Change in Inflammatory Markers (hsCRP) From Baseline to 14 Days

Outcome measures

Measure	Alirocumab n=10 Participants Alirocumab (150 mg) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin. alirocumab	Placebo n=10 Participants Placebo (sterile saline) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin. placebo
Change in Inflammatory Markers (hsCRP)	-4 percent change Interval -55.0 to 71.0	-33 percent change Interval -48.0 to 13.0

Adverse Events

Alirocumab

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Alirocumab n=10 participants at risk Alirocumab (150 mg) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin. alirocumab	Placebo n=10 participants at risk Placebo (sterile saline) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin. placebo
Infections and infestations sepsis	0.00% 0/10 • From baseline to 14 days	10.0% 1/10 • Number of events 1 • From baseline to 14 days
Nervous system disorders stroke	10.0% 1/10 • Number of events 1 • From baseline to 14 days	0.00% 0/10 • From baseline to 14 days
Cardiac disorders admission for heart failure	20.0% 2/10 • Number of events 2 • From baseline to 14 days	0.00% 0/10 • From baseline to 14 days
Cardiac disorders admission for unstable angina	10.0% 1/10 • Number of events 1 • From baseline to 14 days	0.00% 0/10 • From baseline to 14 days

Other adverse events

Adverse event data not reported

Additional Information

Cory Trankle, MD

Virginia Commonwealth University

Phone: 804-213-2679

Email: cory.trankle@vcuhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place