Efficacy of Alirocumab for Thin-cap fibroatheroma in patients with coronary artery disease estImated by optical coherence tomography trial.
- Conditions
- coronary artery disease
- Registration Number
- JPRN-jRCT1051180063
- Lead Sponsor
- Otake Hiromasa
- Brief Summary
Intensive lipid-lowering therapy with alirocumab plus 10 mg/dL rosuvastatin helps stabilize vulnerable plaque by increasing fibrous-cap thickness. Our findings provide mechanistic insight into the efficacy of adding alirocumab to standard-dose statins to improve clinical outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method