Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06683131
PHASE4

Effectiveness of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor Initiation Before Percutaneous Coronary Intervention on Acute Myocardial Infarction Patients

Sponsor: The Affiliated Hospital of Xuzhou Medical University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if drug tafolecimab works to treat participants with acute myocardial infarction (AMI) scheduled for primary percutaneous coronary intervention (PCI). It will also learn about the safety of drug tafolecimab. The main questions it aims to answer are: * Does drug tafolecimab lower the risk of 1-year major adverse cardiovascular events? * Does drug tafolecimab improve the coronary microvascular dysfunction? * What medical problems do participants have when administering drug tafolecimab by injection? Researchers will compare the results administering drug tafolecimab or not to see if drug tafolecimab works to treat AMI. Participants will: * Administer drug tafolecimab by injection or not every month for 12 months * Receive the standard of care of AMI * Complete the measurement of coronary angiography-derived microcirculation resistance index after PCI * Complete cardiac magnetic resonance after PCI if available * Visit the clinic at 1,6,12 months after the first administration for checkups and tests * Report any discomfort, event or queries at any time

Official title: IMpact of PCSK9 inhibitoR initiatiOn Before Percutaneous Coronary Intervention on Coronary microVascular Dysfunction and Events for Acute Myocardial Infarction: a Multi-center, Open-label, Randomized, Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1160

Start Date

2025-11-20

Completion Date

2027-11-30

Last Updated

2025-11-21

Healthy Volunteers

No

Interventions

DRUG

Tafolecimab

450mg of tafolecimab (150mg each one) was injected subcutaneously before primary PCI and then 150mg subcutaneously injected every half a month till totally 12 months.

Locations (13)

Taihe County People's Hospital

Fuyang, Anhui, China

The Fifth People's Hospital of Huai'an City

Huai'an, Jiangsu, China

Lianyungang Municipal Dongfang Hospital

Lianyungang, Jiangsu, China

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Nanjing, Jiangsu, China

Jiangsu Provincial People's Hospital (The First Affiliated Hospital of Nanjing Medical University)

Nanjing, Jiangsu, China

The Fourth Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Suqian Hospital of Jiangsu Provincial People's Hospital

Suqian, Jiangsu, China

The affiliated hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Suining County People's Hospital

Xuzhou, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Xuzhou Mining Group General Hospital

Xuzhou, Jiangsu, China

Peking University First Hospital

Beijing, China

Shanghai Tenth People's Hospital

Shanghai, China