Acute Coronary SyndromePhase 2EVACSNCT03515304
Evolocumab in Acute Coronary Syndrome
A Phase 2 study testing Evolocumab in people with Acute Coronary Syndrome, run by Johns Hopkins University at 1 site in United States.
Trial summary
Vascular and myocardial inflammation are significantly increased in Acute Coronary Syndrome (ACS) patients, are closely correlated to LDL-C levels, and are associated with these adverse consequences in the post-ACS patient population. Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Evolocumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2018to 25 Mar 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non ST segment elevation myocardial infarction
- Troponin I >/ 5.0 ng/dL
- Permission of attending physician
Who cannot join
- ST elevation myocardial infarction
- Patients requiring invasive hemodynamic support
- Scheduled for cardiac surgery
- Current or prior treatment with a PCSK9 antibody
- Current participation in an intervention clinical trial
- Female of childbearing potential who has not used acceptable method(s) of birth control for at least one month prior to screening
Show all 10Show fewer
- Contraindication to statin therapy
- Subject likely not able to complete protocol related visits or procedures
- Latex allergy
- History of hypersensitivity to any monoclonal antibody
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolocumab in Acute Coronary Syndrome: A Double-Blind Randomized Placebo Controlled Study
Vascular and myocardial inflammation are significantly increased in Acute Coronary Syndrome (ACS) patients, are closely correlated to LDL-C levels, and are associated with these adverse consequences in the post-ACS patient population. Serum proprotein convertase subtilisin/kerin type 9 (PCSK9) levels are also increased in ACS, may raise LDL-C, and the investigators' pre-clinical studies indicate that PCSK9 is also a potent inducer of vascular inflammation. The addition of the PCSK9 antibody evolocumab, currently approved to lower LDL-C in certain patient populations, to current medical therapies would appear to be of particular benefit in an important subset of ACS patients, those with non-ST elevation myocardial infarction (NSTEMI) by markedly reducing LDL-C, stabilizing vulnerable plaque, and limiting inflammation-associated myocardial cell loss and resultant dysfunction.
Read the detailed description
In a placebo-controlled, randomized double blind trial, the addition of evolocumab to standard care in NSTEMI patients (1) decreases LDL-C during hospitalization and at 30 days, (2) decreases vascular/plaque and myocardial inflammation as assessed by Positron Emission Tomography (PET) scanning at 30 days, and improves (3) serum markers of endothelial function at hospital discharge and at 30 days, and (4) echocardiographic assessment of left ventricular function at 30 days and six months.
This is the first PCSK9 inhibitor trial which examines these outcomes in the ACS patient population. It will provide valuable data on the extent and time course of LDL-C reduction as well as the impact of inhibition on inflammatory markers and on imaging assessment of vascular and myocardial inflammation, all of which may significantly impact important clinical outcomes in this high risk patient cohort.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Evolocumab, Placebo
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabDrug
Also called Repatha
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
PlaceboDrug
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
| Study group | Role | What they receive |
|---|---|---|
| Evolocumab | Experimental | 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission. Receives: Drug: Evolocumab |
| Placebo | Placebo comparator | Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in LDL-Cholesterol
Measured: Baseline to 30 days
Change From Baseline in Target to Background Ratio Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Scans
PET Imaging for Inflammation: Change from baseline in target to background ratio Fluorodeoxyglucose (FDG) PET scans in the myocardium.
Measured: Baseline to 30 days
Secondary outcomes (7)
Left Ventricular Volume as Assessed by Echocardiography
Evaluation of left ventricular volume (ml) by echocardiography
Measured: Baseline, day 30 and 6 months
Ejection Fraction as Assessed by Echocardiography
Evaluation of ejection fraction (%) by echocardiography
Measured: Baseline, day 30 and 6 months
Plasma Proprotein Convertase Subtilisin Kexin-9 (PCSK9) Levels (ng/ml)
Change from baseline in PCSK9 serum levels
Measured: Baseline, day 30 and 6 months
PET-FDG Assessed Vascular Inflammation as Assessed by Standardized Uptake Value (SUV)
Target artery to background ratio endpoint (standardized uptake value) for left carotid artery
Measured: Baseline to day 30
High Sensitivity C-reactive Protein (Hs-CRP) Serum Levels
hs-CRP serum levels (mg/L)
Measured: Baseline, day 30 and 6 months
Change in Serum Levels of Interleukin 6
Change in baseline in serum levels of Interleukin 6 (pg/mL)
Measured: Baseline, day 30 and 6 months
Serum Levels of Interleukin 10
Serum levels of Interleukin 10 (pg/mL)
Measured: Baseline, day 30 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start20 May 2018
- Primary completion25 Oct 2024
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Thorsten M Leucker, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515304
- Sponsor's protocol ID
- IRB00156313
- Acronym
- EVACS
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2018
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atallah M, Harb T, Nasrallah N, Jones SR, Gerstenblith G, Tsimikas S, Leucker TM. Oxidized phospholipid dynamics in the early post-infarction period: Effects of PCSK9 inhibition with evolocumab. Atherosclerosis. 2025 Oct;409:120469. doi: 10.1016/j.atherosclerosis.2025.120469. Epub 2025 Aug 5.
PubMed 40780143Vavuranakis MA, Jones SR, Ziogos E, Blaha MJ, Williams MS, Foran P, Schindler TH, Lai S, Schulman SP, Gerstenblith G, Leucker TM. The Trajectory of Lipoprotein(a) During the Peri- and Early Postinfarction Period and the Impact of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition. Am J Cardiol. 2022 May 15;171:1-6. doi: 10.1016/j.amjcard.2022.01.058. Epub 2022 Mar 21.
PubMed 35314069
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolocumab in Acute Coronary Syndrome: A Double-Blind Randomized Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT03515304
- Acronym / sponsor ID
- EVACS / IRB00156313
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 20 May 2018 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 3 May 2018 (actual)
- Results
- Posted 24 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vascular and myocardial inflammation are significantly increased in Acute Coronary Syndrome (ACS) patients, are closely correlated to LDL-C levels, and are associated with these adverse consequences in the post-ACS patient population. Serum proprotein convertase subtilisin/kerin type 9 (PCSK9) levels are also increased in ACS, may raise LDL-C, and the investigators' pre-clinical studies indicate that PCSK9 is also a potent inducer of vascular inflammation. The addition of the PCSK9 antibody evolocumab, currently approved to lower LDL-C in certain patient populations, to current medical therapies would appear to be of particular benefit in an important subset of ACS patients, those with non-ST elevation myocardial infarction (NSTEMI) by markedly reducing LDL-C, stabilizing vulnerable plaque, and limiting inflammation-associated myocardial cell loss and resultant dysfunction.
Detailed description
In a placebo-controlled, randomized double blind trial, the addition of evolocumab to standard care in NSTEMI patients (1) decreases LDL-C during hospitalization and at 30 days, (2) decreases vascular/plaque and myocardial inflammation as assessed by Positron Emission Tomography (PET) scanning at 30 days, and improves (3) serum markers of endothelial function at hospital discharge and at 30 days, and (4) echocardiographic assessment of left ventricular function at 30 days and six months.
This is the first PCSK9 inhibitor trial which examines these outcomes in the ACS patient population. It will provide valuable data on the extent and time course of LDL-C reduction as well as the impact of inhibition on inflammatory markers and on imaging assessment of vascular and myocardial inflammation, all of which may significantly impact important clinical outcomes in this high risk patient cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| Evolocumab | Experimental | Drug: Evolocumab420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission. |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non ST segment elevation myocardial infarction
- Troponin I >/ 5.0 ng/dL
- Permission of attending physician
Key exclusion criteria (10 listed)
- ST elevation myocardial infarction
- Patients requiring invasive hemodynamic support
- Scheduled for cardiac surgery
- Current or prior treatment with a PCSK9 antibody
- Current participation in an intervention clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvolocumabAlso: Repatha420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission. | Drug | Evolocumab |
| PlaceboPlacebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission. | Drug | Placebo |
Primary outcome
Percent Change in LDL-Cholesterol
Time frame: Baseline to 30 days
Change From Baseline in Target to Background Ratio Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Scans
Time frame: Baseline to 30 days
PET Imaging for Inflammation: Change from baseline in target to background ratio Fluorodeoxyglucose (FDG) PET scans in the myocardium.
7 secondary outcomes
Left Ventricular Volume as Assessed by Echocardiography
Time frame: Baseline, day 30 and 6 months
Ejection Fraction as Assessed by Echocardiography
Time frame: Baseline, day 30 and 6 months
Plasma Proprotein Convertase Subtilisin Kexin-9 (PCSK9) Levels (ng/ml)
Time frame: Baseline, day 30 and 6 months
PET-FDG Assessed Vascular Inflammation as Assessed by Standardized Uptake Value (SUV)
Time frame: Baseline to day 30
High Sensitivity C-reactive Protein (Hs-CRP) Serum Levels
Time frame: Baseline, day 30 and 6 months
Change in Serum Levels of Interleukin 6
Time frame: Baseline, day 30 and 6 months
Serum Levels of Interleukin 10
Time frame: Baseline, day 30 and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40780143Atallah M, Harb T, Nasrallah N, Jones SR, Gerstenblith G, Tsimikas S, Leucker TM. Oxidized phospholipid dynamics in the early post-infarction period: Effects of PCSK9 inhibition with evolocumab. Atherosclerosis. 2025 Oct;409:120469. doi: 10.1016/j.atherosclerosis.2025.120469. Epub 2025 Aug 5.
- Derived from this study: PubMed 35314069Vavuranakis MA, Jones SR, Ziogos E, Blaha MJ, Williams MS, Foran P, Schindler TH, Lai S, Schulman SP, Gerstenblith G, Leucker TM. The Trajectory of Lipoprotein(a) During the Peri- and Early Postinfarction Period and the Impact of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition. Am J Cardiol. 2022 May 15;171:1-6. doi: 10.1016/j.amjcard.2022.01.058. Epub 2022 Mar 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thorsten M Leucker, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Evolocumab in people with Acute Coronary Syndrome, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in LDL-Cholesterol (time frame: Baseline to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03515304, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.