NCT03515304CompletedPhase 2
Evolocumab in Acute Coronary Syndrome
Evolocumab in Acute Coronary Syndrome: A Double-Blind Randomized Placebo Controlled Study
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 10 Apr 2018
- Start date
- 20 May 2018
- Primary completion date
- 25 Oct 2024
- Lead sponsor
- Johns Hopkins University
- Diseases
- Coronary artery disease
- NCT number
- NCT03515304
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 60
- From 20 May 2018 to the primary completion date, 25 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or prior treatment with a PCSK9 antibody
- Female of childbearing potential who has not used acceptable method(s) of birth control for at least one month prior to screening
- Contraindication to statin therapy
Other illness
- ST elevation myocardial infarction
- Scheduled for cardiac surgery
- Latex allergy
- History of hypersensitivity to any monoclonal antibody
Other
- Patients requiring invasive hemodynamic support
- Current participation in an intervention clinical trial
- Subject likely not able to complete protocol related visits or procedures
Who the study is looking for
- Non ST segment elevation myocardial infarction
- Troponin I \>/ 5.0 ng/dL
- Permission of attending physician
Age in the registry: 25 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Steven Paul Schulman Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.