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Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population (EMPACT): A Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fuwai Hospital
RECRUITING
Beijing
Tangshan Central Hospital
RECRUITING
Tangshan
Contact Information
Primary
Na-Qiong Wu, Doctor
wunaqiong@fuwaihospital.org
86-88398866
Backup
Zheng Yin, Doctor
yinzheng@fuwai.com
86-88398866
Time Frame
Start Date: 2023-11-11
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 3684
Treatments
Experimental: Tafolecimab group
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.
Active_comparator: control group
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).
Sponsors
Collaborators: Innovent Biologics, Inc.
Leads: China National Center for Cardiovascular Diseases

This content was sourced from clinicaltrials.gov

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