NCT03552432

Brief Summary

the purpose of this study is to show that alirocumab with statin therapy have a s tronger stabilizing effect on vulnerable plaque in coronary artery disease than statin alone administration

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Aug 2017

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

3.1 years

First QC Date

May 7, 2018

Last Update Submit

November 11, 2018

Conditions

Coronary Artery DiseaseThin-cap fIbroatheroma

Keywords

alirocumabThin-cap fIbroatheroma (TCFA)vulnerable plaqueOptical Coherence Tomography (OCT)

Outcome Measures

Primary Outcomes (1)

  • the change in fibrous cap thickness

    the absolute change in minimum fibrous-cap thickness between baseline and 36-week follow-up

    9 month

Secondary Outcomes (46)

  • the change in fibrous cap thickness

    9 month

  • the change in lipid index

    9 month

  • the change in lipid index

    9 month

  • the change in lipid length,

    9 month

  • the change in lipid length,

    9 month

  • +41 more secondary outcomes

Study Arms (2)

Alirocumab therapy group

EXPERIMENTAL

start with alirocumab 75mg per 2weeks and rosuvastatin 10mg per day

Drug: Alirocumab

standard statin therapy group

NO INTERVENTION

start with only rosuvastatin 10mg per day

Interventions

AlirocumabDRUG

the administration of Alirocumab by Subcutaneous injection 75mg every 2 weeks plus Rosuvastatin10mg/daily by oral for 9 months

Alirocumab therapy group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent PCI for ACS or stable coronary heart disease
  • Patients with LDL-C ≥70 mg/dL under daily 10mg rosuvastatin
  • Patients who have been had TCFA detected by OCT
  • Patients aged ≥20 years old at PCI
  • Patients who agree to be enrolled in the trial giving signed written informed consent

You may not qualify if:

  • Patients who have been treated previously with at least one dose of any anti-PCSK9 monoclonal antibody
  • Patients had uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg) between the time of PCI and randomization visit
  • Known hypersensitivity to alirocumab or rosuvastatin
  • All contraindications to alirocumab and/or rosuvastatin as displayed in the respective national product labeling for these treatments
  • Known history of hemorrhagic stroke
  • Currently under treatment for cancer
  • Patients on lipoprotein apheresis
  • Patients with severe liver or renal dysfunction
  • Pregnant or breast-feeding women
  • Considered by the investigator as inappropriate for this study for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kobe University Graduate School of Medicine, Department of Cardiology

Kobe, Hyōgo, 650-0017, Japan

RECRUITING

Related Publications (1)

  • Otake H, Sugizaki Y, Toba T, Nagano Y, Tsukiyama Y, Yanaka KI, Yamamoto H, Nagasawa A, Onishi H, Takeshige R, Nakano S, Matsuoka Y, Tanimura K, Kawamori H, Shinke T, Hirata KI. Efficacy of alirocumab for reducing plaque vulnerability: Study protocol for ALTAIR, a randomized controlled trial in Japanese patients with coronary artery disease receiving rosuvastatin. J Cardiol. 2019 Mar;73(3):228-232. doi: 10.1016/j.jjcc.2018.11.012. Epub 2018 Dec 19.

    PMID: 30579806DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

alirocumab

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Hiromasa Otake, M.D, Ph,D

    Kobe University Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hiromasa Otake, M.D, Ph,D

CONTACT

+81-78-382-5846hotake@med.kobe-u.ac.jp

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

May 7, 2018

First Posted

June 11, 2018

Study Start

August 23, 2017

Primary Completion

September 30, 2020

Study Completion

September 30, 2021

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

JP(1)