Efficacy of Alirocumab for Thin-cap fibroatheroma in patients with coronary artery disease estImated by optical coherence tomography trial.

JRCT ID: jRCT1051180063

Registered date:14/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: coronary artery disease
• Date of first enrollment: 05/09/2017
• Target sample size: 24
• Study type: Interventional

Intervention(s)

Patients in the alirocumab arm will receive subcutaneous alirocumab 75 mg every 2 weeks (Q2W) in addition to statin therapy (rosuvastatin 10 mg/day).
Patients in the standard-of-care arm will receive rosuvastatin 10 mg/day, with initiation and/or dose adjustment of non-statin lipid-lowering drugs to achieve an LDL-C target <70 mg/dL

Outcome(s)

• Primary Outcome: the change in minimum fibrous-cap thickness between baseline and the 36-week follow-up

Secondary Outcome

1: the absolute change in lipid length
2: the percentage change in lipid length
3: the absolute change in max lipid arc
4: the percentage change in max lipid arc
5: the absolute change in mean lipid arc
6: the percentage change in mean lipid arc
7: the absolute change in lipid index
8: the percentage change in lipid index
9: the absolute change in macrophage grade
10: the percentage change in macrophage grade
11: he absolute change in minimum lumen area
12: the percentage change in minimum lumen area
13: the absolute change in fibrous cap thickness
14: the percentage number of thin-cap fibroatheroma
15: the absolute change in LDL-C
16: the percentage change in LDL-C
17: the absolute change in HDL-C
18: the percentage change in HDL-C
19: the absolute change in non-HDL-C
20: the percentage change in non-HDL-C
21: the absolute change in apolipoprotein B
22: the percentage change in apolipoprotein B
23: the absolute change in triglyceride
24: the percentage change in triglyceride
25: the absolute change in Lp (a)
26: the percentage change in Lp (a)
27: the absolute change in hs-CRP
28: the percentage change in hs-CRP
29: the absolute change in IL-1 beta
30: the percentage change in IL-1 beta
31: the absolute change in IL-6
32: the percentage change in IL-6
33: the absolute change in TNF-alpha
34: the percentage change in TNF-alpha
35: the absolute change in MCP-1
36: the percentage change in MCP-1
37: the absolute change in VCAM-1
38: the percentage change in VCAM-1
39: the absolute change in ICAM-1
40: the percentage change in ICAM-1
41: the absolute change in MMP-2
42: the percentage change in MMP-2
43: the absolute change in MMP-9
44: the percentage change in MMP-9
45: the absolute change in free PCSK9
46: the percentage change in free PCSK9

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

ALTAIR employs the following eligibility criteria:
1: Patients who underwent PCI for ACS or stable coronary heart disease
ACS is defined as ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or unstable angina. STEMI is defined as symptoms suggesting ischemia (e.g., chest pain or shortness of breath), with more than or equal 1 mm of ST elevation in more than or equal 2 consecutive chest leads or in more than or equal 2 consecutive limb leads on electrocardiography or with a new left bundle branch block, and with elevated cardiac marker levels (cardiac troponin I levels above the 99th percentile upper reference limit). NSTEMI is defined as symptoms suggesting ischemia, with ST depression more than 0.5 mm (0.05 mV), negative T-wave (more than or equal 0.1 mV), or transient ST elevation less than or equal 0.5 mm, and with elevated cardiac marker levels (as described for STEMI). Unstable angina is defined as symptoms suggesting ischemia without elevation of myocardial enzyme levels plus one of the following: ST depression more than or equal 0.5 mm or negative T-wave (more than or equal 0.1 mm); culprit coronary lesion responsible for ACS confirmed on diagnostic imaging (e.g. coronary angiography, multidetector computed tomography); new decrease in wall motion on cardiac ultrasonography; and evidence of reversible decrease in myocardial blood flow on pharmacological or exercise stress testing. Stable CAD is defined as more than or equal 90% stenosis of a coronary artery confirmed on diagnostic imaging or evidence of reversible decrease in myocardial blood flow on pharmacological or exercise stress testing, with or without symptoms suggesting ischemia (except for STEMI, NSTEMI, and unstable angina).
2: Patients who have been treated stain therapy or who have been started statin therapy after PCI
3: Patients who have been detected TCFA by OCT at PCI
4: Patients aged more than or equal 20 years old at PCI
5: Patients who agree to be enrolled in the trial giving signed written informed consent

Exclude criteria

Exclusion criteria are follows;
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: Patients with LDL-C <70 mg/dL
4: Known hypersensitivity to alirocumab or rosuvastatin
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: All contraindications to rosuvastatin as displayed in the respective national product labeling for these treatments
10: All contraindications to alirocumab as displayed in the respective national product labeling for these treatments
11: Pregnant or breast-feeding women
12: Considered by the investigator as inappropriate for this study for any reason

Related Information

• Primary Sponsor: Otake Hiromasa
• Secondary ID(s): UMIN000029533