Acute Coronary SyndromeSHAWNNCT05457582
PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With ACS After PCI
A study testing PCSK 9 Inhibitor plus high-intensity statin in people with Acute Coronary Syndrome and Hyperlipidemias, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The primary objective was to evaluate the effect of PCSK 9 Inhibitor (initiated within 4 h from PCI for the culprit lesion) with high-intensity statin treatment, compared to placebo with high-intensity statin treatment, on cardiovascular events (including cardiovascular death, myocardial infarction, stroke… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Hyperlipidemias, Percutaneous Coronary Intervention
- What is being tested?
- PCSK 9 Inhibitor plus high-intensity statin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,212 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2023to 30 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject, or their legal guardian, must have a clear understanding of the trial's design and treatment procedures. They must provide written informed consent before any trial-specific tests or procedures are conducted.
- Both male and female subjects aged ≥18 years.
- Subjects who have experienced an ACS and have undergone PCI for culprit lesions (either QFR or FFR < 0.8) are eligible. ACS is defined as:
- Unstable angina (characterized by rest pain lasting between 5 and 30 minutes or worsening exertional angina accompanied by either transient ST segment depression or elevation, or angiography revealing visually estimated diameter stenosis of 90% or greater, or a ruptured plaque or thrombotic lesion), or (2) Non-ST elevation myocardial infarction, indicated by positive troponin levels consistent with the clinical syndrome and non-ST segment elevation, or (3) ST elevation myocardial infarction, indicated by positive troponin levels consistent with the clinical syndrome and ST-segment elevation.
- 4. Low-density lipoprotein cholesterol levels must meet the following criteria:
- Low-density lipoprotein cholesterol ≥70 mg/dL (≥1.8 mmol/L) in patients who have been on a stable high-intensity statin regimen for at least 4 weeks before enrollment.
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- Low-density lipoprotein cholesterol ≥90 mg/dL (≥2.3 mmol/L) in patients who have been on a moderate or low-intensity statin regimen before enrollment.
- Low-density lipoprotein cholesterol ≥125 mg/dL (≥3.2 mmol/L) in patients who are statin-naïve or have not been on a stable statin regimen for at least 4 weeks before enrollment.
- 5. Subjects must have at least one culprit lesion for ACS in a major native coronary artery (diameter stenosis >70% with a QFR or FFR<0.8), and have at least one non-culprit vessel disease (diameter stenosis ≤70% with a QFR or FFR ≥0.8).
Who cannot join
- Fasting serum triglyceride levels exceeding 400 mg/dL (exceeding 4.52 mmol/L) before randomization.
- Coronary artery disease is located within a saphenous vein graft or an arterial graft.
- Residual diameter stenosis greater than 50% as determined by visual examination after percutaneous coronary intervention of the culprit lesion.
- TIMI (Thrombolysis in Myocardial Infarction) flow less than 3 in the culprit vessel after PCI.
- Unstable clinical status, characterized by hemodynamic (including cardiogenic shock) or electrical instability.
- Uncontrolled hypertension, indicated by multiple readings with systolic blood pressure (SBP) exceeding 180 mmHg or diastolic blood pressure (DBP) exceeding 110 mmHg.
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- New York Heart Association (NYHA) Class III or IV, and an already known left ventricular ejection fraction (LVEF) below 30%.
- Known history of hemorrhagic stroke in last 180 days before randomization.
- Uncontrolled cardiac arrhythmia, defined as recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response that has not been controlled by medications in the past 3 months before screening.
- Severe renal dysfunction, defined by an estimated glomerular filtration rate (eGFR) below 30 ml/min/1.73m².
- Active liver disease or hepatic dysfunction.
- Known intolerance to rosuvastatin or any statin.
- Known allergy to contrast medium, heparin, aspirin, ticagrelor, prasugrel, or clopidogrel.
- Subjects who have previously received PCSK9 inhibitors.
- Subjects who have received cholesterol ester transfer protein inhibitors within the past 12 months before enrollment.
- Treatment with systemic steroids or systemic cyclosporine within the past 3 months.
- Known active infection or major hematologic, metabolic, or endocrine dysfunction, as determined by the Investigator.
- Planned non-cardiac surgery within the next 12 months.
- Subjects who will not be able to attend the required study visits, as determined by the Investigator.
- Currently enrolled in another investigational device or drug study.
- History of cancer within the past 5 years, unless adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer.
- Estimated life expectancy of less than 12 months.
- Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy, or hysterectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study
The primary objective was to evaluate the effect of PCSK 9 Inhibitor (initiated within 4 h from PCI for the culprit lesion) with high-intensity statin treatment, compared to placebo with high-intensity statin treatment, on cardiovascular events (including cardiovascular death, myocardial infarction, stroke, re-hospitalization due to acute coronary syndromes or heart failure, or any ischemia-driven coronary revascularization) in patients with acute coronary syndrome and multiple lesions. Alirocumab was used before June 10, 2025; Tafolecimab has been used from June 10, 2025 onward.
Read the detailed description
Patients with acute coronary syndrome (ACS) are at high-risk. ACS patients are commonly associated with multiple lesions or multivessel disease. Percutaneous coronary intervention (PCI) is an effective treatment for culprit lesions in ACS. Statin at high-intensity is recommended by current guidelines in order to prevent/slow the progression of non-culprit disease or restenosis. PCSK9 inhibitor serves as the most powerful medication in lowering LDL via promoting the expression of LDL receptors in the liver. However, if the combination of PCSK9 inhibitor with high-intensity statin treatment could significantly reduce the cardiovascular events in patients with ACS who underwent PCI remains unknown. Alirocumab was used before June 10, 2025; Tafolecimab has been used from June 10, 2025 onward.
- Conditions
- Acute Coronary Syndrome, Hyperlipidemias, Percutaneous Coronary Intervention, Cardiovascular Events
- Being tested
- Placebo plus high-intensity statin, PCSK 9 Inhibitor plus high-intensity statin
- Medical subject headings
- Acute Coronary Syndrome, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo plus high-intensity statinDrug
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen, Q2W, and oral administration of rosuvastatin (20 mg, once daily).
PCSK 9 Inhibitor plus high-intensity statinDrug
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen, Q2W, and oral administration of rosuvastatin (20 mg, once daily).
| Study group | Role | What they receive |
|---|---|---|
| Placebo plus high-intensity statin | Placebo comparator | Participants received placebo subcutaneous injections once every 2 weeks (Q2W) plus high-intensity statin treatment (Rosuvastatin, 20 mg, once daily) Receives: Drug: Placebo plus high-intensity statin |
| PCSK 9 Inhibitor plus high-intensity statin | Active comparator | Participants received PCSK 9 Inhibitor Q2W subcutaneous injections Receives: Drug: PCSK 9 Inhibitor plus high-intensity statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular events
Cardiovascular events defined as the composite of cardiovascular death, myocardial infarction, stroke or transit ischemic attack, re-hospitalization due to unstable angina or heart failure, or any ischemia-driven coronary revascularization.
Measured: 12 months after randomization
Secondary outcomes (8)
Cardiovascular death
It will be adjudicated by an independent external CEC according to protocol defined definition.
Measured: 12 months after randomization
All cause death
It is defined as any death from randomization to the last visit.
Measured: 12 months after randomization
Myocardial infarction
It will be adjudicated by an independent external CEC.
Measured: 12 months after randomization
Stroke
stroke will be adjudicated by an independent external CEC.
Measured: 12 months after randomization
Ischemia-driven coronary revascularization
It will be adjudicated by an independent external CEC.
Measured: 12 months after randomization
Re-hospitalization due to unstable angina or heart failure
It will be adjudicated by an independent external CEC.
Measured: 12 months after randomization
Diagnostic malignant tumor
It will be adjudicated by an independent external CEC.
Measured: 12 months after randomization
PCSK9 inhibitors or statin intolerance
It will be adjudicated by an independent external CEC.
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start30 Mar 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly (at a ratio of 1:1) assigned to PCSK9 inhibitor plus high-intensity statin or placebo plus high-intensity statin group, and then the results at 1 year, 2- or 3-year are compared
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,212 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Nanjing Medical University
- Responsible party
- Principal investigator, Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Shao-Liang Chen, MD, PhD, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457582
- Sponsor's protocol ID
- NMU20220701
- Acronym
- SHAWN
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2022
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study
- ClinicalTrials.gov ID
- NCT05457582
- Acronym / sponsor ID
- SHAWN / NMU20220701
- Conditions
- Acute Coronary Syndrome, Hyperlipidemias, Percutaneous Coronary Intervention, Cardiovascular Events
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,212 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Nanjing Medical University
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective was to evaluate the effect of PCSK 9 Inhibitor (initiated within 4 h from PCI for the culprit lesion) with high-intensity statin treatment, compared to placebo with high-intensity statin treatment, on cardiovascular events (including cardiovascular death, myocardial infarction, stroke, re-hospitalization due to acute coronary syndromes or heart failure, or any ischemia-driven coronary revascularization) in patients with acute coronary syndrome and multiple lesions. Alirocumab was used before June 10, 2025; Tafolecimab has been used from June 10, 2025 onward.
Detailed description
Patients with acute coronary syndrome (ACS) are at high-risk. ACS patients are commonly associated with multiple lesions or multivessel disease. Percutaneous coronary intervention (PCI) is an effective treatment for culprit lesions in ACS. Statin at high-intensity is recommended by current guidelines in order to prevent/slow the progression of non-culprit disease or restenosis. PCSK9 inhibitor serves as the most powerful medication in lowering LDL via promoting the expression of LDL receptors in the liver. However, if the combination of PCSK9 inhibitor with high-intensity statin treatment could significantly reduce the cardiovascular events in patients with ACS who underwent PCI remains unknown. Alirocumab was used before June 10, 2025; Tafolecimab has been used from June 10, 2025 onward.
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
- Participants are randomly (at a ratio of 1:1) assigned to PCSK9 inhibitor plus high-intensity statin or placebo plus high-intensity statin group, and then the results at 1 year, 2- or 3-year are compared
| Arm | Type | Receives |
|---|---|---|
| Placebo plus high-intensity statin | Placebo comparator | Drug: Placebo plus high-intensity statinParticipants received placebo subcutaneous injections once every 2 weeks (Q2W) plus high-intensity statin treatment (Rosuvastatin, 20 mg, once daily) |
| PCSK 9 Inhibitor plus high-intensity statin | Active comparator | Drug: PCSK 9 Inhibitor plus high-intensity statinParticipants received PCSK 9 Inhibitor Q2W subcutaneous injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subject, or their legal guardian, must have a clear understanding of the trial's design and treatment procedures. They must provide written informed consent before any trial-specific tests or procedures are conducted.
- Both male and female subjects aged ≥18 years.
- Subjects who have experienced an ACS and have undergone PCI for culprit lesions (either QFR or FFR < 0.8) are eligible. ACS is defined as:
- Unstable angina (characterized by rest pain lasting between 5 and 30 minutes or worsening exertional angina accompanied by either transient ST segment depression or elevation, or angiography revealing visually estimated diameter stenosis of 90% or greater, or a ruptured plaque or thrombotic lesion), or (2) Non-ST elevation myocardial infarction, indicated by positive troponin levels consistent with the clinical syndrome and non-ST segment elevation, or (3) ST elevation myocardial infarction, indicated by positive troponin levels consistent with the clinical syndrome and ST-segment elevation.
- Low-density lipoprotein cholesterol ≥70 mg/dL (≥1.8 mmol/L) in patients who have been on a stable high-intensity statin regimen for at least 4 weeks before enrollment.
Key exclusion criteria (23 listed)
- Fasting serum triglyceride levels exceeding 400 mg/dL (exceeding 4.52 mmol/L) before randomization.
- Coronary artery disease is located within a saphenous vein graft or an arterial graft.
- Residual diameter stenosis greater than 50% as determined by visual examination after percutaneous coronary intervention of the culprit lesion.
- TIMI (Thrombolysis in Myocardial Infarction) flow less than 3 in the culprit vessel after PCI.
- Unstable clinical status, characterized by hemodynamic (including cardiogenic shock) or electrical instability.
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 |
|---|---|---|
| Placebo plus high-intensity statinAdministered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen, Q2W, and oral administration of rosuvastatin (20 mg, once daily). | Drug | Placebo plus high-intensity statin |
| PCSK 9 Inhibitor plus high-intensity statinAdministered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen, Q2W, and oral administration of rosuvastatin (20 mg, once daily). | Drug | PCSK 9 Inhibitor plus high-intensity statin |
Primary outcome
Cardiovascular events
Time frame: 12 months after randomization
Cardiovascular events defined as the composite of cardiovascular death, myocardial infarction, stroke or transit ischemic attack, re-hospitalization due to unstable angina or heart failure, or any ischemia-driven coronary revascularization.
8 secondary outcomes
Cardiovascular death
Time frame: 12 months after randomization
All cause death
Time frame: 12 months after randomization
Myocardial infarction
Time frame: 12 months after randomization
Stroke
Time frame: 12 months after randomization
Ischemia-driven coronary revascularization
Time frame: 12 months after randomization
Re-hospitalization due to unstable angina or heart failure
Time frame: 12 months after randomization
Diagnostic malignant tumor
Time frame: 12 months after randomization
PCSK9 inhibitors or statin intolerance
Time frame: 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- 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.
Shao-Liang Chen, MD, PhD study chair
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCSK 9 Inhibitor plus high-intensity statin in people with Acute Coronary Syndrome and Hyperlipidemias, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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 9 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 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 China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Cardiovascular events (time frame: 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2026.