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Clinical study single center, prospective, randomized, controlled (vs. no supplement), open-label, blinded assessor (the doctor who will perform the Doppler ultrasound at 6 and 12 months will not know the treatment given to the patient, because the diagnostic test in question is considered operator-dependent), a "parallel group", which aims is evaluate the reduction in the level of calcium in the carotid artery and the carotid atherosclerotic plaques, on a sample of 60 subjects presenting subcritical calcified lesions of the carotid bifurcation with a range of 40-60%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with K2 | Experimental | The nutraceutical product (PLAK2) based on vitamin K2, will be administered once a day (a tablet 800mg) for 12 months. All patients enrolled will continue to be treated according to the clinical standard (100 mg Cardioaspirin, cp 1 day : Acetylsalicylic acid) |
|
| Control group (no vitamin K2) | No Intervention | The control group did not take the supplement of Vitamin K2. All patients enrolled will continue to be treated according to the clinical standard (100 mg Cardioaspirin, cp 1 day : Acetylsalicylic acid) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutraceutical product based on vitamin K2 (PLAK2) | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction of calcium content, to 12 months, at the level of carotid atheromatous plaque | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Hospital | Milan | 20132 | Italy |
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