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The study is an open-label, multicenter, and randomized study. The objective of this study is to demonstrate the effect of PCSK9 inhibitor on ACS patients with multivessel disease and relatively low LDL-C levels or LDL-C levels lower than the recommended target.
The primary outcome was the rate of major adverse cardiac events (CV death, non-fatal myocardial infarction, documented unstable angina that requires admission into a hospital, all coronary revascularization with either PCI or CABG occurring at least 30 days after randomization, Non-fatal stroke) at 1 year. The secondary efficacy endpoints were individual components of the major adverse cardiac events, all cause death, and the percent change in LDL-C, Apo B, HDL-C, Lp(a) after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard of care: management as recommended in ESC/EAS 2019 guidelines, within reimbursement criteria | |
| treatment | Experimental | On top of Standard of care, Evolocumab (Repatha®) 140 mg or Alirocumab(Praluent) 75mg every two weeks: first subcutaneous injection at the time of randomization, followings during 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repatha or Praluent | Drug | Evolocumab (Repatha®) 140 mg or Alirocumab (Praluent) 75mg every two weeks, first subcutaneous injection at the time of randomization, followings during 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | The primary endpoint in the CHOICE study was the rate of major adverse cardiac events at 1 year. The definition of major adverse cardiac events was a composite of:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint | The secondary efficacy endpoints were individual components of the major adverse cardiac events, all cause death, and the percent change in LDL-C, Apo B, HDL-C, Lp(a) at 1 year. | 12 months |
| Secondary Endpoint |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C577155 | evolocumab |
| C571059 | alirocumab |
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|
the percent change in LDL-C, Apo B, HDL-C, Lp(a) at 1 year.
| 12 months |