Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amgen | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicenter, randomized, open label study with blinded outcome assessment to evaluate the impact of additional/intensive LDL-cholesterol reduction with evolocumab on carotid artery atherosclerotic plaques in higher risk subjects with severe asymptomatic but vulnerable plaques.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug (Evolocumab) | Active Comparator | Individuals randomized to this arm will administer Evolocumab subcutaneously (SC) every two weeks (Q2W) for 26 weeks. |
|
| No Drug (Standard of Care) | No Intervention | Individuals randomized to this arm will not administer a placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolocumab | Drug | Autoinjector 1-mL deliverable volume of 140 mg/mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in lipid rich necrotic core (LRNC) volume | As measured by MRI | Baseline to end of treatment (average of 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vessel wall volume | As measured by MRI | Baseline to end of treatment (average of 6 months) |
| Change in vessel lumen volume | As measured by MRI |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Histology and Morphology | Obtained at time of CEA | At the end of treatment (average of 6 months) |
| Lipid Levels | Serum lipid levels | Baseline to end of treatment (average of 6 months) |
Inclusion Criteria:
Exclusion Criteria:
Additional Inclusion Criteria
If all eligibility criteria listed above are met, participants with only one high risk feature will undergo a time-of-flight MR angiogram, where one additional inclusion criteria will be assessed to confirm eligibility:
1. Evidence of IPH on MRI
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole Cooke | Contact | (416) 864-6060 | 43932 | Nicole.Cooke@unityhealth.to |
| Name | Affiliation | Role |
|---|---|---|
| Mohammed Al-Omran, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North York Diagnostic and Cardiac Centre | Recruiting | North York | Ontario | M6B 3H7 | Canada |
Not provided
Twenty-six week treatment with or without evolocumab in addition to current medical management.
Not provided
Not provided
Not provided
| Baseline to end of treatment (average of 6 months) |
| East Toronto Vascular Clinic | Recruiting | Toronto | Ontario | M4L3Y3 | Canada |
|
| St. Michael's Hospital | Recruiting | Toronto | Ontario | Canada |
|
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C577155 | evolocumab |
Not provided
Not provided
Not provided