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The purpose of this study is to evaluate the effect of proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibitors added to regular statin therapy on target lesion failure (TLF) and arteriosclerosis progression in patients with chronic total occlusions (CTOs) undergoing successful percutaneous coronary intervention (PCI).
Chronic total occlusions (CTOs) are found in 15-25% of patients with stable angina pectoris. The presence of a CTO indicates unfavorable prognosis, with higher rate of major adverse cardiovascular events. Statins are frequently used after PCI in order to lower LDL cholesterol levels and reduce the chances of coronary artery obstruction recurring. Despite this preventive measure, high risk for restenosis and re-occlusion was observed a significant proportion of patients with CTOs undergoing PCI.
Proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibitors represent a novel class of lipid-lowering drugs leading to rapid, profound, and consistent reductions in LDL-C levels. The effect of PCSK9 inhibitor in patients with CTO, after a recent PCI is not known.
In this study the investigators want to evaluate the effect of the PCSK9 inhibitor on neointimal hyperplasia and target lesion failure (TLF) in patients with CTOs receiving regular statin treatment. A serial of intravascular ultrasound imaging study will be performed to determine the arteriosclerosis progression at 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Participants will receive PCSK9 inhibitors added to guideline recommended statin therapy. |
|
| Control arm | Active Comparator | Patients will continue to taking guideline recommended statin therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCSK9 inhibitor | Drug | Evolocumab per every two weeks, starting at day 1 and up to week 48, added to guideline recommended statin therapy.. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in percent plaque volume and plaque burden. | Change in percent plaque volume and plaque burden by intravascular ultrasound (IVUS) between PCSK9 inhibitors group and control group. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Target Lesion Failure (TLF) | TLF is defined as a composite of: all cardiac death, target vessel myocardial infarction (SCAI definition), and clinically driven target lesion revascularization (TLR). | 12 months |
| Neointimal volume with intravascular ultrasound (IVUS) (mm3 per 1mm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Wang, MD | Contact | +8615311765609 | huaianwangxu@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Lin Zhao, MD | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| C577155 | evolocumab |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
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| Statin | Drug | Guideline recommended statin therapy. |
|
|
Comparison of neointima volume by IVUS between PCSK9 inhibitors group and control group. |
| 12 months |
| Ischemia | Ischemic burden assessed with CMR from baseline to 3 and 12 months follow-up | 12 months |
| Change in left ventricular systolic function assessed with CMR | The left ventricular ejection fraction assessed with CMR from baseline to 3 and 12 months follow up | 12 months |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |