NCT06096909RecruitingPhase 4
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population (EMPACT): A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 3684 (estimated)
- First submitted
- 28 Sept 2023
- Start date
- 11 Nov 2023
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Diseases
- Coronary artery disease
- NCT number
- NCT06096909
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 3684
- From 11 Nov 2023 to the primary completion date, 1 Mar 2028
- 2 sites 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
- Previous hemorrhagic cerebrovascular disease history;
- Intolerance to statins or cholesterol absorption inhibitors;
Other illness
- Severe heart failure (Killip III or IV) or cardiogenic shock;
- poorly controlled hypertension;
- malignant tumor;
Lab values
- 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
Other
- Uncontrolled or recurrent arrhythmic events;
- Intolerance to injections;
- Life expectancy \<1 year;
- poor compliance.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Tangshan Central Hospital Coordinator of this site? Confirm its status | Tangshan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.