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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

PCSK9 inhibitor

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early PCSK9 inhibitor treatment group

Group Type EXPERIMENTAL

alirocumab

Intervention Type DRUG

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

conventional treatment group

Group Type OTHER

conventional treatment

Intervention Type OTHER

conventional treatment were given according to international uniformguidelines

Interventions

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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

Intervention Type DRUG

conventional treatment

conventional treatment were given according to international uniformguidelines

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Hou Lei

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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