Status:
NOT_YET_RECRUITING
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Lead Sponsor:
China National Center for Cardiovascular Diseases
Collaborating Sponsors:
Innovent Biologics, Inc.
Conditions:
Acute Coronary Syndrome
Non ST Segment Elevation Acute Coronary Syndrome
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 possi...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Intolerance to statins or cholesterol absorption inhibitors;
- Intolerance to injections;
- Life expectancy \<1 year;
- poor compliance.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
3684 Patients enrolled
Trial Details
Trial ID
NCT06096909
Start Date
November 1 2023
End Date
November 1 2027
Last Update
October 24 2023
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