Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04851769 |
| Other study ID # |
anzhen201803 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
March 2, 2019 |
| Est. completion date |
March 1, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
Beijing Anzhen Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study is a prospective, open-label, randomized, single-center study involving patients
with intermediate coronary lesions (50%-70% diameter stenosis) and who have elevated LDL-C
values (LDL-C≥100 mg/dL) despite stable statin therapy.
Eligible patients are randomized to receive either alirocumab or standard-of-care (1:1). The
last dose of alirocumab will be given at week 34. Patients in the alirocumab arm will receive
alirocumab 75 mg Q2W added to statin therapy (atorvastatin 20 mg/day or rosuvastatin
10mg/day). Patients in the standard-of-care arm will continue to receive atorvastatin 20
mg/day or rosuvastatin 10 mg/day. OCT images will be acquired at the baseline and at week 36
± 2 weeks follow-up.
Description:
The study is a prospective, open-label, randomized, single-center study involving patients
with intermediate coronary lesions (50%-70% diameter stenosis) and who have elevated LDL-C
values (LDL-C≥100 mg/dL) despite stable statin therapy.
Eligible patients included those who are (I) at least 18 years of age, (II) diagnosed as
stable coronary artery disease or acute coronary syndrome during admission (III) undergoing
clinically indicated coronary angiography and identified with at least one intermediate
lesion (50%-70% diameter stenosis) on de novo coronary arteries, (IV) have an elevated LDL-C
values (LDL-C≥100 mg/dL) despite taken rosuvastatin 10 mg/day or atorvastatin 20 mg/day for
2-4 weeks after initiation or with maximally tolerated statin therapy, (V) able to provide
written, informed consent.
The study included a 36-week open-label treatment period (including post-treatment OCT
imaging), starting within 4 weeks of baseline coronary angiogram. During the open-label
treatment period, patients are randomized to receive either alirocumab or standard-of-care
(1:1). The last dose of alirocumab will be given at week 34.
Patients in the alirocumab arm will receive alirocumab 75 mg Q2W added to statin therapy
(atorvastatin 20 mg/day or rosuvastatin 10mg/day). Patients in the standard-of-care arm will
continue to receive atorvastatin 20 mg/day or rosuvastatin 10 mg/day. Statin dose escalation
or adding concomitant non-statin lipid-lowering therapy would be considered by their
responsible physician to achieve an LDL-C target <100 mg/dL. Antithrombotic therapy and other
concomitant medications are exclusively decided by the responsible physicians. Follow-up
coronary angiograms and OCT imaging analyses of the same vessels will be carried out at the
end of treatment period (at week 36 ± 2 weeks, depending on patient availability) in both
study arms. Regular medical examination and laboratory tests will be conducted at weeks 4,
12, 24, and 36. All enrolled patients are monitored and evaluated for safety and any other
adverse events during the study period.
