NCT05292404 Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction
| NCT ID | NCT05292404 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Shanghai Tong Ren Hospital |
| Condition | Acute Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 160 participants in total. It began in 2022-10-01 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multi-center, prospective, randomized, controlled study. The patients with STEMI who were to undergo PPCI were divided into PCSK9 inhibitor group (n=80) and conventional treatment group (n=80) using the interactive web response system (IWRS), at a 1:1 ratio. In the PCSK9 inhibitor group, a dose of PCSK9 inhibitor (alirocumab) was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months; the control group received conventional treatment. Cardiac Magnetic Resonance Imaging (MRI) were used to measure myocardial salvage index at 1 week after operation as primary endpoints. Eject fraction at 6 months after operation will also be measured by MRI as secondary endpoints. Serum TnI/T，CKMB levels were detected q8h for three times and and LDL-C levels were detected at 1 month, 3 months and 6 months after operation. Blood inflammation indicators were detected before and 1 week after the operation, and 6 months after the operation.
Eligibility Criteria
Inclusion Criteria: 1. The age is greater than 18 years old and less than or equal to 80 years old. 2. Patients who are clinically diagnosed with STEMI onset within 24 hours and who are planning to undergo PPCI . 3. Signed informed consent. Exclusion Criteria: 1. Patients who are allergic to PCSK9 inhibitors. 2. Multivessel disease planned for selective intervention within half a year. 3. Patients who have previously undergone revascularization. 4. Pregnant women or women who plan to become pregnant in the next 2 years. 5. Patients whose life expectancy is less than 1 year. 6. Severe liver or kidney dysfunction (ALT\>5 times ULA, eGFR\<15ml/min/1.73m2) 7. Known active malignant tumor diseases. 8. Patients considered by the investigator to be unsuitable to participate in this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05292404 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Acute Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05292404 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05292404 currently recruiting?
Yes, NCT05292404 is actively recruiting participants. Contact the research team at Dr_houlei@163.com for enrollment information.
Where is the NCT05292404 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China, Shanghai, China, Shanghai, China and 1 additional location.
Who is sponsoring the NCT05292404 clinical trial?
NCT05292404 is sponsored by Shanghai Tong Ren Hospital. The trial plans to enroll 160 participants.