Assessing Coronary Non-Culprit Plaque Early with Start of PCSK9 Inhibitors in Acute Myocardial Infarction (ACCESS-AMI)
Launched by YUN DAI CHEN · Feb 25, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The ACCESS-AMI clinical trial is investigating whether a medication called PCSK9 inhibitors can help improve heart health in patients who have had a heart attack (also known as acute myocardial infarction or AMI). The study aims to find out if giving these medications either shortly before or after a procedure to open blocked arteries can make the plaque in the arteries more stable and reduce inflammation. Researchers will compare the effects of PCSK9 inhibitors with a combination treatment of statins and ezetimibe, both of which are commonly used to lower cholesterol, to see which approach better prevents further heart problems.
To participate in this trial, individuals must be at least 18 years old and have recently been hospitalized for a heart attack. They should have had a procedure to treat the blocked artery and have at least two other arteries with moderate blockages. Participants will receive either the PCSK9 inhibitors or the combination therapy for a year and will undergo follow-up tests to monitor their heart health. It’s important to note that certain health issues, like severe heart or kidney problems, may exclude someone from participating. This study is set to start in January 2024, and anyone interested should discuss it with their doctor for more information.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age ≥18 years old.
- • 2. Admitted to hospital for acute myocardial infarction (STEMI, NSTEMI) and successfully underwent PCI of the infarct vessel.
- • 3. Coronary angiography revealed two non-infarct-related arteries with non-blocking lesions (diameter stenosis of 40-70%).
- • 4. Able to sign informed consent.
- • 5. Willing to undergo 1-year follow-up.
- Exclusion Criteria:
- • 1. Left main artery disease or severe coronary artery calcification;
- • 2. Hemodynamic instability or uncontrolled arrhythmia;
- • 3. History of coronary artery bypass;
- • 4. severe renal insufficiency, active liver disease or liver insufficiency, hematological disease, metabolic or endocrine dysfunction, systemic infection, active malignant tumor and other potentially life-threatening diseases, or the expected survival time is \< 1 year;
- • 5. Received any PCSK9 inhibitor treatment within the previous 3 months;
- • 6. Pregnant or nursing women or women planning pregnancy;
- • 7. The researcher determined that it was not suitable for inclusion in the group.
About Yun Dai Chen
Yun Dai Chen is a dedicated clinical trial sponsor focused on advancing healthcare through innovative research and development. Committed to the highest standards of scientific integrity and ethical conduct, the organization specializes in the design, implementation, and management of clinical trials across various therapeutic areas. With a robust team of experienced professionals, Yun Dai Chen aims to facilitate the discovery and evaluation of novel treatments, ensuring that patient safety and regulatory compliance are paramount throughout the clinical research process. Through collaboration with leading medical institutions and researchers, the organization strives to contribute to the global advancement of medical knowledge and improve patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beijing, Beijing, China
Beijing, , China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported