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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001912-50 | EudraCT Number |
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| Name | Class |
|---|---|
| HeartFlow, Inc. | INDUSTRY |
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This study assess in patients with stable chest pain and coronary artery disease (CAD) determined by coronary CTA whether cholesterol lowering with regression of coronary adverse plaque characteristics is associated with recovery of impaired flow
Multicenter, prospective study. 105 patients with stable chest pain, and moderate CAD, statin naive (and LDL cholesterol >2 mM), and at least one translesional FFRct value <0.81 are randomized (patients with significant CAD in the left main or other proximal segments are excluded from the study) to either "atorvastatin 40 mg daily" or "rosuvastatin 40 mg + ezetimibe 10 mg daily" treatment. Patients are followed for 18 months with 2 CT scans performed at 9 months and one at 18 months. At each 4 CT scans blinded corelab analyses of plaque characteristics and volumes as well as FFRct calculation (HeartFlow) are performed. The primary endpoint is changes in FFRct values from 0 to 18 months. Secondary endpoints are 1 changes in FFRct values from 0 to 9 months of follow-up, and changes in low density plaques volumes and number of lesions with positive remodeling over time relative to changes in LDL cholesterol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual care lipid lowering | Active Comparator | Usual care: atorvastatin 40 mg |
|
| Intensive lipid lowering | Experimental | Intensive: rosuvastatin 40 mg + ezetimibe 10 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High intensity lipid lowering | Drug | Two different regimens of drugs with different effects on LDL lowering |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in FFRct values | CT derived FFR | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in FFRct values | CT derived FFR | 9 months |
| Changes in low density plaque volumes | CT determined plaque volumes | 0-9, and 0-18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bjarne Norgaard, MD, PhD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Denamrk | 8300 | Denmark |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |