Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction

Acute Myocardial Infarction Clinical Trial

Official title:

Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction： a Muti-center, Open-label, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05292404
• Other study ID #: ShanghaiTRH-HL2022
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Shanghai Tong Ren Hospital
• Contact: Lei Hou, doctor
• Phone: 86-13564868096
• Email: Dr_houlei[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• alirocumab
In the PCSK9 inhibitor group, a dose of PCSK9 inhibitor (alirocumab,75mg) was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months

Other:
• conventional treatment
conventional treatment were given according to international uniformguidelines

Locations

Country	Name	City	State
China	nineth people's hospital, School of Medicine, shanghai jiaotong university	Shanghai	Shanghai
China	Shanghai chest hospital	Shanghai	Shanghai
China	Shanghai tongren hospital	Shanghai	Shanghai
China	Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	tenth people's hospital, tongji university, Shanghai	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Tong Ren Hospital	China Cardiovascular Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	myocardial salvage index	measured by Magnetic Resonance Imaging (MRI)	1 week after operation
Secondary	Eject fraction	measured by MRI	at 6 months after operation