Clinical trial NCT03552432: The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography
Official title: The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography: Single Center, Randomized, Open-label, Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Thin-cap fIbroatheroma
Keywords: alirocumab
Thin-cap fIbroatheroma (TCFA)
vulnerable plaque
Optical Coherence Tomography (OCT)
Lead sponsor: Kobe University
Sponsor class: INDUSTRY
First posted: 2018-06-11
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: The investigators investigate to evaluate the efficacy of alirocumab for vulnerable plaque. The investigators enrolled the patient with standard statin therapy who were detected vulnerable plaque by optical coherence tomography, and categorized into two group; the patients with alirocumab and rosuvastatin were categorized alirocumab therapy group, and the patients with rosuvastatin alone were categorized standard statin therapy group. The investigators compare these two group for outcomes.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: the change in fibrous cap thickness
timeFrame: 9 month
Secondary outcomes:
measure: the change in fibrous cap thickness
timeFrame: 9 month
measure: the change in lipid index
timeFrame: 9 month
measure: the change in lipid index
timeFrame: 9 month
measure: the change in lipid length,
timeFrame: 9 month
measure: the change in lipid length,
timeFrame: 9 month
measure: the change in mean lipid arc
timeFrame: 9 month
measure: the change in mean lipid arc
timeFrame: 9 month
measure: the change in max lipid arc
timeFrame: 9 month
measure: the change in max lipid arc
timeFrame: 9 month
measure: the change in macrophage grade
timeFrame: 9 month
measure: the change in macrophage grade
timeFrame: 9 month
measure: the change in minimum lumen area
timeFrame: 9 month
measure: the change in minimum lumen area
timeFrame: 9 month
measure: the number of thin-cap fibroatheroma
timeFrame: 9 month
measure: the change in total cholesterol
timeFrame: 9 month
measure: the change in total cholesterol
timeFrame: 9 month
measure: the change in LDL-C
timeFrame: 9 month
measure: the change in LDL-C
timeFrame: 9 month
measure: the change in HDL-C
timeFrame: 9 month
measure: the change in HDL-C
timeFrame: 9 month
measure: the change in non-HDL-C
timeFrame: 9 month
measure: the change in non-HDL-C
timeFrame: 9 month
measure: the change in apolipoprotein B
timeFrame: 9 month
measure: the change in apolipoprotein B
timeFrame: 9 month
measure: the change in Lp(a)
timeFrame: 9 month
measure: the change in Lp(a)
timeFrame: 9 month
measure: the change in hs-CRP
timeFrame: 9 month
measure: the change in hs-CRP
timeFrame: 9 month
measure: the change in IL-1β
timeFrame: 9 month
measure: the change in IL-1β
timeFrame: 9 month
measure: the change in IL-6
timeFrame: 9 month
measure: the change in IL-6
timeFrame: 9 month
measure: the change in TNF-α
timeFrame: 9 month
measure: the change in TNF-α
timeFrame: 9 month
measure: the change in MCP-1
timeFrame: 9 month
measure: the change in MCP-1
timeFrame: 9 month
measure: the change in MMP-2
timeFrame: 9 month
measure: the change in MMP-2
timeFrame: 9 month
measure: the change in MMP-9
timeFrame: 9 month
measure: the change in MMP-9
timeFrame: 9 month
measure: the change in VCAM-1
timeFrame: 9 month
measure: the change in VCAM-1
timeFrame: 9 month
measure: the change in ICAM-1
timeFrame: 9 month
measure: the change in ICAM-1
timeFrame: 9 month
measure: the change in free PCSK9
timeFrame: 9 month
measure: the change in free PCSK9
timeFrame: 9 month
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe University Graduate School of Medicine, Department of Cardiology
state: Hyogo
Study officials:
affiliation: Kobe University Graduate School of Medicine
name: Hiromasa Otake, M.D, Ph,D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.