UMIN-ICDS Clinical Trial

Public title

Individualized Maintenance Lipid-Lowering Strategies After Initial Intensive PCSK9 Inhibition in Patients With Acute Myocardial Infarction: A Prospective Multicenter Serial Coronary CT Angiography Study

Acronym

MAINTAIN-PCSK9 Study

Scientific Title

Individualized Maintenance Lipid-Lowering Strategies After Initial Intensive PCSK9 Inhibition in Patients With Acute Myocardial Infarction: A Prospective Multicenter Serial Coronary CT Angiography Study

Scientific Title:Acronym

MAINTAIN-PCSK9 Study

Region

Japan

Condition

Acute myocardial infarction

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare changes in whole-coronary noncalcified plaque volume (NCPV) from landmark CCTA to follow-up CCTA approximately 12 months later between two maintenance lipid-lowering strategies in patients who initiated PCSK9 inhibitor therapy within 90 days after acute myocardial infarction and continued it for at least 9 months: Strategy A, continuation of PCSK9 inhibitor therapy, and Strategy B, discontinuation of PCSK9 inhibitor therapy with goal-directed intensive oral lipid-lowering therapy targeting LDL-C <55 mg/dL. The study will also evaluate pFAI, CT-FFR, lipid biomarkers, 5-year clinical outcomes, and the feasibility of maintaining LDL-C <55 mg/dL without PCSK9 inhibitor reinitiation in Strategy B.

Basic objectives2

Others

Basic objectives -Others

To evaluate the association between maintenance lipid-lowering strategies and coronary plaque changes after initial intensive PCSK9 inhibition and the feasibility of goal-directed intensive oral lipid-lowering therapy after PCSK9 inhibitor discontinuation.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Absolute change in whole-coronary noncalcified plaque volume (delta NCPV) from landmark CCTA to follow-up CCTA (target 12 months after landmark CCTA

Key secondary outcomes

1.Changes in LAPV, TPV, CPV, pFAI, and CT-FFR/CT-PPG-related indices from landmark to follow-up CCTA.
2.Changes and longitudinal exposure metrics for LDL-C, non-HDL-C, ApoB, Lp(a), and hsCRP, including time-weighted mean LDL-C/ApoB, time in target range for LDL-C <55 mg/dL, and cumulative lipid exposure.
3.LDL-C <55 mg/dL attainment, PCSK9 inhibitor-free LDL-C target maintenance in Strategy B, implementation of bempedoic acid-containing regimens, changes in lipid-lowering therapy, adherence, and safety.
4.Five-year 3P-MACE (CV death, nonfatal MI, and ischemic stroke), 4P-MACE (3P-MACE plus unplanned coronary revascularization), and individual clinical events.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

19

years-old

<=

Age-upper limit

Not applicable

Gender

Male

Key inclusion criteria

1.Age grater than 18 years at landmark.
2.Index STEMI or NSTEMI treated with PCI of the culprit lesion.
3.At least one 50-90 persent diameter stenosis in a nonculprit coronary lesion at index AMI that was deferred from revascularization in routine clinical care.
4.PCSK9 inhibitor initiated within 90 days after index AMI and continued for at least 9 months before landmark.
5.Landmark scheduled 12 months after index AMI, with landmark CCTA performed or planned as part of routine clinical care.
6.Follow-up CCTA expected to be clinically performed 12 months after landmark CCTA.
7.Major clinical information from index AMI to landmark is available.
8.Receiving lipid-lowering therapy based on a maximally tolerated statin at landmark.
9.Strategy A or Strategy B targeting LDL-C less than 55 mg/dL is selected in routine clinical care.
10.Written informed consent obtained.

Key exclusion criteria

1.Planned staged PCI or CABG for the target nonculprit lesion.
2.Untreated significant left main coronary stenosis (diameter stenosis greater than 50%).
3.Previous CABG.
4.Contrast-enhanced CCTA considered inappropriate in routine clinical care, including eGFR less than 30 mL/min/1.73 m2 or acute kidney injury, history of severe iodinated contrast hypersensitivity/anaphylaxis, pregnancy or possible pregnancy, or other medical reasons.
5.Insufficient information regarding the index AMI, PCSK9 inhibitor exposure, or nonculprit lesions before landmark.
6.Unable to classify clearly as Strategy A or Strategy B at landmark.
7.Unable to provide written informed consent.
8.Considered inappropriate for enrollment by the investigator.

Target sample size

362

Name of lead principal investigator

1st name	Kai
Middle name
Last name	Ninomiya

Organization

Iwate Medical University

Division name

Division of Cardiology, Department of Internal Medicine

Zip code

028-3695

Address

2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate 028-3695, Japan

TEL

019-613-7111

Email

knino@iwate-med.ac.jp

Name of contact person

1st name	Yumiko
Middle name
Last name	Okuyama

Organization

Iwate medical university

Division name

Division of Cardiology, Department of Internal Medicine

Zip code

028-3695

Address

2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate 028-3695, Japan

TEL

019-613-7111

Homepage URL

Email

yokuyama@iwate-med.ac.jp

Institute

Iwate Medical University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Iwate Medical University Ethics Committee

Address

2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate 028-3695, Japan

Tel

019-651-5110

Email

kenkyu-rinri@j.iwate-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

岩手医科大学附属病院（岩手県）
昭和医科大学病院（東京都）
聖マリアンナ医科大学病院（神奈川県）
九州大学病院（福岡県）
愛知医科大学病院（愛知県）
上尾中央総合病院（埼玉県）
静岡市立静岡病院（静岡県）
東京慈恵会医科大学葛飾医療センター（東京都）
横浜南共済病院（神奈川県）
岩手県立中部病院（岩手県）

Date of disclosure of the study information

2026

Year

09

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

09

Month

06

Day

Date of IRB

Anticipated trial start date

2026

Year

11

Month

01

Day

Last follow-up date

2033

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a multicenter, nonrandomized, active-comparator landmark observational study using a dual-entry design for the serial CCTA cohort. In Route 1, eligible patients who newly initiate a PCSK9 inhibitor within 90 days after index AMI are prospectively enrolled consecutively and assessed for eligibility for the serial CCTA cohort at landmark. In Route 2, patients who were not previously enrolled in the PCSK9 inhibitor initiation cohort but meet eligibility criteria near landmark are directly enrolled; pre-landmark information from index AMI to landmark is collected retrospectively from medical records after written consent. Follow-up after landmark is prospective in both routes. Strategy A (PCSK9 inhibitor continuation) and Strategy B (PCSK9 inhibitor discontinuation with goal-directed intensive oral lipid-lowering therapy targeting LDL-C <55 mg/dL) are selected by patients and treating physicians as part of routine clinical care and are not assigned by the study. CCTA is not mandated solely for research; routine-care landmark and follow-up CCTA images meeting study requirements are used for research analysis. The target sample size of the serial CCTA cohort is 362. No fixed target sample size is specified for the prospective PCSK9 inhibitor initiation cohort.

Registered date

2026

Year

09

Month

06

Day

Last modified on

2026

Year

09

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071925