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Alirocumab in Patients With Acute Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT02938949
Recruitment Status : Completed
First Posted : October 19, 2016
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
Regeneron Pharmaceuticals
Sanofi
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Myocardial Infarction
Hypercholesterolemia
Interventions Drug: alirocumab
Drug: placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Alirocumab Placebo
Hide Arm/Group Description

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 (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

Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Alirocumab Placebo Total
Hide Arm/Group Description

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 (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 of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
60
(51 to 66)
56
(48 to 65)
59
(49 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
4
  40.0%
9
  90.0%
13
  65.0%
Male
6
  60.0%
1
  10.0%
7
  35.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  70.0%
9
  90.0%
16
  80.0%
White
3
  30.0%
1
  10.0%
4
  20.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
body mass index  
Median (Inter-Quartile Range)
Unit of measure:  Kilograms per meters squared
Number Analyzed 10 participants 10 participants 20 participants
27.8
(24.2 to 36.8)
31.9
(28.7 to 38.8)
30.9
(25.5 to 37.4)
1.Primary Outcome
Title Changes in Low-density Lipoprotein (LDL) Cholesterol
Hide Description Placebo-corrected percentage change in calculated LDL cholesterol from baseline to day 14
Time Frame baseline and 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alirocumab Placebo
Hide Arm/Group Description:

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 (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 Number of Participants Analyzed 10 10
Median (Inter-Quartile Range)
Unit of Measure: percent change
-73
(-83 to -56)
2
(-12 to 11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change in Inflammatory Markers (hsCRP)
Hide Description Placebo-corrected percentage change in inflammatory markers (hsCRP) from baseline to 3 days
Time Frame baseline to 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Research team was unable to collect samples from 2 Alirocumab participants.
Arm/Group Title Alirocumab Placebo
Hide Arm/Group Description:

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 (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 Number of Participants Analyzed 8 10
Median (Inter-Quartile Range)
Unit of Measure: percent change
58
(-27 to 82)
55
(-25 to 161)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value > 0.20
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change in Inflammatory Markers (hsCRP)
Hide Description Placebo-corrected Percentage Change in Inflammatory Markers (hsCRP) From Baseline to 14 Days
Time Frame baseline to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alirocumab Placebo
Hide Arm/Group Description:

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 (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 Number of Participants Analyzed 10 10
Median (Inter-Quartile Range)
Unit of Measure: percent change
-4
(-55 to 71)
-33
(-48 to 13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.20
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame From baseline to 14 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alirocumab Placebo
Hide Arm/Group Description

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 (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

All-Cause Mortality
Alirocumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
Alirocumab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/10 (40.00%)      1/10 (10.00%)    
Cardiac disorders     
admission for heart failure   2/10 (20.00%)  2 0/10 (0.00%)  0
admission for unstable angina   1/10 (10.00%)  1 0/10 (0.00%)  0
Infections and infestations     
sepsis   0/10 (0.00%)  0 1/10 (10.00%)  1
Nervous system disorders     
stroke   1/10 (10.00%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Alirocumab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cory Trankle, MD
Organization: Virginia Commonwealth University
Phone: 804-213-2679
EMail: cory.trankle@vcuhealth.org
Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02938949    
Other Study ID Numbers: HM20008008
First Submitted: October 18, 2016
First Posted: October 19, 2016
Results First Submitted: June 28, 2019
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019