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

• Sponsor: Shanghai Tong Ren Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05292404
• Collaborator: China Cardiovascular Association (Other)
• Enrollment: 160
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 30
• Patients Per Site: 80
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction	Drug: alirocumab; Other: conventional treatment	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction： a Muti-center, Open-label, Randomized Controlled Trial
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early PCSK9 inhibitor treatment group	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 group	Other: conventional treatment; conventional treatment were given according to international uniformguidelines

Outcome Measures

Primary Outcome Measures

1. myocardial salvage index [1 week after operation]

   measured by Magnetic Resonance Imaging (MRI)

Secondary Outcome Measures

1. Eject fraction [at 6 months after operation]

   measured by MRI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai chest hospital	Shanghai	Shanghai	China	200050
2	Shanghai tongren hospital	Shanghai	Shanghai	China	200050

Sponsors and Collaborators

• Shanghai Tong Ren Hospital
• China Cardiovascular Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hou Lei, Principal Investigator, Shanghai Tong Ren Hospital
• ClinicalTrials.gov Identifier: NCT05292404
• Other Study ID Numbers: ShanghaiTRH-HL2022
• First Posted: Mar 23, 2022
• Last Update Posted: May 25, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Myocardial Infarction; Infarction

Study Results

No Results Posted as of May 25, 2022