Acute Coronary SyndromePhase 4NCT06096909
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
A Phase 4 study testing Tafolecimab, Cholesterol Absorption Inhibitor and Statin in people with Acute Coronary Syndrome and Non ST Segment Elevation Acute Coronary Syndrome, run by China National Center for Cardiovascular Diseases at 2 sites in China.
Trial summary
For patients with ACS undergoing PCI, intensive lipid-lowering including PCSK9 monoclonal antibody should be started as soon as possible, that is, lower LDL-C level should be achieved as soon as possible. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome, Lipid Lowering, Vascular Inflammation
- What is being tested?
- Tafolecimab, Cholesterol Absorption Inhibitor and Statin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,684 participants
- Where
- 2 sitesChina
- Study dates
- 11 Nov 2023to 1 Jun 2028
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 75 years;
- clinical diagnosis with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) ;
- undergoing PCI
- baseline LDL-C 1.8 mmol/L 3.4 mmol/L note: NSTE-ACS includes non-ST-elevation myocardial infarction and unstable angina.
Who cannot join
- Severe heart failure (Killip III or IV) or cardiogenic shock;
- Previous hemorrhagic cerebrovascular disease history;
- Uncontrolled or recurrent arrhythmic events;
- poorly controlled hypertension;
- Severe hepatic and renal insufficiency (ALT/AST> 3 times upper limit of normal, eGFR<30 ml/kg/1.73m2, or ongoing dialysis) or creatine kinase elevation>5 times upper limit of normal
- malignant tumor;
Show all 10Show fewer
- Intolerance to statins or cholesterol absorption inhibitors;
- Intolerance to injections;
- Life expectancy <1 year;
- poor compliance.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Na-Qiong Wu, Doctor, 86-88398866, wunaqiong@fuwaihospital.org
Na-Qiong Wu, Doctor
- Recruiting
Tangshan Central Hospital
Tangshan, Hebei, 063000
Chun-Lai Zhang, 86-0315-6272120
About this study
Official title: Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population (EMPACT): A Randomized Controlled Trial
For patients with ACS undergoing PCI, intensive lipid-lowering including PCSK9 monoclonal antibody should be started as soon as possible, that is, lower LDL-C level should be achieved as soon as possible. Compared with conventional lipid-lowering regimen, it is expected that the occurrence of major adverse cardiovascular events can still be reduced after drug discontinuation. Therefore, the optimization strategy of "for patients with ACS undergoing PCI, intensive lipid-lowering with PCSK9 monoclonal antibody can be started as soon as possible" is proposed.
Read the detailed description
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death worldwide, and its incidence is increasing yearly in China, which has not yet reached the inflection point. Acute coronary syndrome (ACS) is a severe form of ASCVD, and lipid-lowering and antithrombotic therapy are the two core therapies. In the latest ESC/EAS guidelines for lipid management, for ACS patients, the target LDL-C is <1.4 mmol/L and ≥50% reduction from baseline, and specific initiatives to achieve this target are proposed, emphasizing the timing of clinical application and status of the novel lipid-lowering agent-proprotein convertase subtilisin/kexin type 9 monoclonal antibody (PCSK9) (hereafter referred to as PCSK9 antibody). In recent years, large-scale randomized controlled trials and outcomes of PCSK9 antibodies have demonstrated that PCSK9 antibodies further reduce adverse cardiovascular events by significantly lowering LDL-C levels under the background statin (±cholesterol absorption inhibitor ) therapy. The introduction of PCSK9 antibodies allowed for the reduction of LDL-C to unprecedented levels. From the "cholesterol principle" perspective, it is theoretically reasonable to add a PCSK9 inhibitor to statins as soon as possible during hospitalization for ACS patients. Still, there is no clear evidence from large RCTs. Current evidence supports that for ACS patients, PCSK9 antibodies could be used only when LDL-C is still not up to standard based on treatment with the maximum tolerable dose of statins during the first 2-3 months. However, the immediate initiation of PCSK9 antibodies during the acute phase of ACS (before hospital discharge) has yet to be studied.
- Conditions
- Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome, Lipid Lowering, Vascular Inflammation
- Being tested
- Tafolecimab, Cholesterol Absorption Inhibitor, Statin
- 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.
TafolecimabDrug
The PCSK9 mAb in this study is defined as Tafolecimab 150mg q2w subcutaneously. For the two groups of lipid-lowering regimens, the lipid-lowering drug regimens other than PCSK9 mAb were maintained throughout the study as much as possible in accordance with the guidelines related to blood lipids, provided that no serious safety problems occurred.
Cholesterol Absorption InhibitorDrug
Cholesterol absorption inhibitors (like Ezetimibe and Hybutimibe) are based on physician decisions, but need to be routinely dosed. Examples of Medications that Meet Study Requirements: Ezetimibe 10mg Po qd.
StatinDrug
Statin are based on physician decisions, but need to be routinely dosed. Examples of Medications that Meet Study Requirements: Atorvastatin 20mg Po qn, Rosuvastatin 10mg Po qn or Pitavastatin 4mg Po qn.
| Study group | Role | What they receive |
|---|---|---|
| Tafolecimab group | Experimental | Intensive LLT with tafolecimab (150 mg every 2 weeks) add to statin ± cholesterol absorption inhibitor.
The intervention of this trial is divided to two different stages to stimulate the comparison of "SESS" or "step by step" lipid lowering strategy, including 1) conventional LLT (statin ± cholesterol absorption inhibitor) with tafolecimab (150 mg every two weeks) or not till the end of 24 weeks, and 2) physician decisions according to the local guideline of cholesterol management (< 1.8 mmol/L) in both groups from the start of 25th week till the end of 104 weeks. The statin refers to the maximal tolerated dose of statins every day. The cholesterol absorption inhibitors includes ezetimibe 10 mg and hybutimibe 10 mg every day. The statin or cholesterol absorption inhibitors use before enrollment will not be inhibited, while any injection of PCSK9 inhibitors within six months before enrollment will not be allowed. Other non-LDL-C lowering drugs can be also used and recorded in detail. Receives: Drug: Tafolecimab; Drug: Statin |
| control group | Active comparator | Conventional lipid lowering therapy with statin ± cholesterol absorption inhibitor.The statin refers to the maximal tolerated dose of statins every day. The cholesterol absorption inhibitors includes ezetimibe 10 mg and hybutimibe 10 mg every day. The statin or cholesterol absorption inhibitors use before enrollment will not be inhibited, while any injection of PCSK9 inhibitors within six months before enrollment will not be allowed. Other non-LDL-C lowering drugs can be also used and recorded in detail. After enrollment, a recommended statin and cholesterol absorption inhibitors using guideline to adjust LLT will be sent to each physicians to calculate how to make each patients achieve the LDL-C target. Adjustments will be permitted within 24 weeks only under predefined conditions: 1) the occurrence of serious LLT-related side effects, or 2) for patients in the control group, if their LDL-C levels are inadequately controlled via protocol-specified criteria at Visit 1 (Week 4). Receives: Drug: Cholesterol Absorption Inhibitor; Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular and cerebrovascular events (MACCE)
The primary endpoint of this trial is major adverse cardiovascular and cerebrovascular events at visit 4 (week 104), defined as the composite endpoints of cardiovascular death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina and coronary revascularization. Coronary revascularization included PCI or coronary artery bypass grafting (CABG). The coronary revascularization will be conducted based on the presence of ischemia. To evaluate the ischemic need for coronary revascularization, specific assessments will be utilized. Laboratory examinations will include blood tests to check for markers of myocardial injury, such as troponins. Electrocardiograms will be assessed. Unstable angina is defined as typical angina symptoms that have worsened in the past month, with a single episode lasting more than half a minute and that do not resolve spontaneously. The definition of MI is referenced from the fourth Universal Definition of Myocardial Infarction (UDMI)
Measured: week 104
Secondary outcomes (3)
major adverse cardiovascular and cerebrovascular events
The key secondary endpoint is the incidence of MACCE at week 26 (Visit 2), defined as a composite of cardiovascular death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina, and coronary revascularization.
Measured: week 26
A composite of primary outcome or all-cause death
Including all-cause death, cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina, and coronary revascularization). The coronary revascularization includes coronary intervention (PCI), coronary artery bypass grafting (CABG).
Measured: Week 104
Lipid control outcome
Lipid control outcome is the proportion of patients achieving an LDL-C reduction of ≥50% from baseline and attaining an LDL-C level of <1.4 mmol/L.
Measured: week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start11 Nov 2023
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Jun 2028 (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 China National Center for Cardiovascular DiseasesThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 3,684 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Innovent Biologics, Inc.
- Responsible party
- Sponsor
- Investigators
- Na-Qiong Wu, Doctor, Principal investigator, Chinese Academy of Medical Sciences, Fuwai HospitalYong-Jian Wu, Doctor, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096909
- Sponsor's protocol ID
- 2021-CXGC03-002
- Status last verified
- Feb 2026
- First submitted
- 28 Sep 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population (EMPACT): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06096909
- Acronym / sponsor ID
- 2021-CXGC03-002
- Conditions
- Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome, Lipid Lowering, Vascular Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,684 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Innovent Biologics, Inc.
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 24 Oct 2023 (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.
For patients with ACS undergoing PCI, intensive lipid-lowering including PCSK9 monoclonal antibody should be started as soon as possible, that is, lower LDL-C level should be achieved as soon as possible. Compared with conventional lipid-lowering regimen, it is expected that the occurrence of major adverse cardiovascular events can still be reduced after drug discontinuation. Therefore, the optimization strategy of "for patients with ACS undergoing PCI, intensive lipid-lowering with PCSK9 monoclonal antibody can be started as soon as possible" is proposed.
Detailed description
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death worldwide, and its incidence is increasing yearly in China, which has not yet reached the inflection point. Acute coronary syndrome (ACS) is a severe form of ASCVD, and lipid-lowering and antithrombotic therapy are the two core therapies. In the latest ESC/EAS guidelines for lipid management, for ACS patients, the target LDL-C is <1.4 mmol/L and ≥50% reduction from baseline, and specific initiatives to achieve this target are proposed, emphasizing the timing of clinical application and status of the novel lipid-lowering agent-proprotein convertase subtilisin/kexin type 9 monoclonal antibody (PCSK9) (hereafter referred to as PCSK9 antibody). In recent years, large-scale randomized controlled trials and outcomes of PCSK9 antibodies have demonstrated that PCSK9 antibodies further reduce adverse cardiovascular events by significantly lowering LDL-C levels under the background statin (±cholesterol absorption inhibitor ) therapy. The introduction of PCSK9 antibodies allowed for the reduction of LDL-C to unprecedented levels. From the "cholesterol principle" perspective, it is theoretically reasonable to add a PCSK9 inhibitor to statins as soon as possible during hospitalization for ACS patients. Still, there is no clear evidence from large RCTs. Current evidence supports that for ACS patients, PCSK9 antibodies could be used only when LDL-C is still not up to standard based on treatment with the maximum tolerable dose of statins during the first 2-3 months. However, the immediate initiation of PCSK9 antibodies during the acute phase of ACS (before hospital discharge) has yet to be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tafolecimab group | Experimental | Drug: Tafolecimab, Drug: StatinIntensive LLT with tafolecimab (150 mg every 2 weeks) add to statin ± cholesterol absorption inhibitor. The intervention of this trial is divided to two different stages to stimulate the comparison of "SESS" or "step by step" lipid lowering strategy, including 1) conventional LLT (statin ± cholesterol absorption inhibitor) with tafolecimab (150 mg every two weeks) or not till the end of 24 weeks, and 2) physician decisions according to the local guideline of cholesterol management (< 1.8 mmol/L) in both groups from the start of 25th week till the end of 104 weeks. The statin refers to the maximal tolerated dose of statins every day. The cholesterol absorption inhibitors includes ezetimibe 10 mg and hybutimibe 10 mg every day. The statin or cholesterol absorption inhibitors use before enrollment will not be inhibited, while any injection of PCSK9 inhibitors within six months before enrollment will not be allowed. Other non-LDL-C lowering drugs can be also used and recorded in detail. |
| control group | Active comparator | Drug: Cholesterol Absorption Inhibitor, Drug: StatinConventional lipid lowering therapy with statin ± cholesterol absorption inhibitor.The statin refers to the maximal tolerated dose of statins every day. The cholesterol absorption inhibitors includes ezetimibe 10 mg and hybutimibe 10 mg every day. The statin or cholesterol absorption inhibitors use before enrollment will not be inhibited, while any injection of PCSK9 inhibitors within six months before enrollment will not be allowed. Other non-LDL-C lowering drugs can be also used and recorded in detail. After enrollment, a recommended statin and cholesterol absorption inhibitors using guideline to adjust LLT will be sent to each physicians to calculate how to make each patients achieve the LDL-C target. Adjustments will be permitted within 24 weeks only under predefined conditions: 1) the occurrence of serious LLT-related side effects, or 2) for patients in the control group, if their LDL-C levels are inadequately controlled via protocol-specified criteria at Visit 1 (Week 4). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 75 years;
- clinical diagnosis with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) ;
- undergoing PCI
- baseline LDL-C 1.8 mmol/L 3.4 mmol/L note: NSTE-ACS includes non-ST-elevation myocardial infarction and unstable angina.
Key exclusion criteria (10 listed)
- Severe heart failure (Killip III or IV) or cardiogenic shock;
- Previous hemorrhagic cerebrovascular disease history;
- Uncontrolled or recurrent arrhythmic events;
- poorly controlled hypertension;
- Severe hepatic and renal insufficiency (ALT/AST> 3 times upper limit of normal, eGFR<30 ml/kg/1.73m2, or ongoing dialysis) or creatine kinase elevation>5 times upper limit of normal
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 |
|---|---|---|
| TafolecimabThe PCSK9 mAb in this study is defined as Tafolecimab 150mg q2w subcutaneously. For the two groups of lipid-lowering regimens, the lipid-lowering drug regimens other than PCSK9 mAb were maintained throughout the study as much as possible in accordance with the guidelines related to blood lipids, provided that no serious safety problems occurred. | Drug | Tafolecimab group |
| Cholesterol Absorption InhibitorCholesterol absorption inhibitors (like Ezetimibe and Hybutimibe) are based on physician decisions, but need to be routinely dosed. Examples of Medications that Meet Study Requirements: Ezetimibe 10mg Po qd. | Drug | control group |
| StatinStatin are based on physician decisions, but need to be routinely dosed. Examples of Medications that Meet Study Requirements: Atorvastatin 20mg Po qn, Rosuvastatin 10mg Po qn or Pitavastatin 4mg Po qn. | Drug | Tafolecimab group, control group |
Primary outcome
Major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: week 104
The primary endpoint of this trial is major adverse cardiovascular and cerebrovascular events at visit 4 (week 104), defined as the composite endpoints of cardiovascular death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina and coronary revascularization. Coronary revascularization included PCI or coronary artery bypass grafting (CABG). The coronary revascularization will be conducted based on the presence of ischemia. To evaluate the ischemic need for coronary revascularization, specific assessments will be utilized. Laboratory examinations will include blood tests to check for markers of myocardial injury, such as troponins. Electrocardiograms will be assessed. Unstable angina is defined as typical angina symptoms that have worsened in the past month, with a single episode lasting more than half a minute and that do not resolve spontaneously. The definition of MI is referenced from the fourth Universal Definition of Myocardial Infarction (UDMI)
3 secondary outcomes
major adverse cardiovascular and cerebrovascular events
Time frame: week 26
A composite of primary outcome or all-cause death
Time frame: Week 104
Lipid control outcome
Time frame: week 104
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 27 Oct 2026.
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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.
Na-Qiong Wu, Doctor principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
Yong-Jian Wu, Doctor principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tafolecimab, Cholesterol Absorption Inhibitor and Statin in people with Acute Coronary Syndrome and Non ST Segment Elevation Acute Coronary Syndrome, run by China National Center for Cardiovascular Diseases at 2 sites 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 4 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Na-Qiong Wu, Doctor (86-88398866, wunaqiong@fuwaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular and cerebrovascular events (MACCE) (time frame: week 104). 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 27 Oct 2026.