Patients with - Stable peripheral artery disease and - Asymptomatic, atherosclerotic plaque/stenosis in the carotid artery; asymptomatic regarding cerebral ischaemia including stroke and transient ischaemic attack (TIA) or amaurosis fugax.
Conditions
Brief summary
More hyperechoic carotid plaques in the intervention group, with 1 year rivaroxaban treatment, compared to placebo over time determined by increase in plaque echogenicity with at least 20 % in grey-median-scale (GSM) registered by ultrasound, as an expression of plaque stabilizaton by rivaroxaban.
Detailed description
volumen, thrombus volumen and intraplaque contrastfilling over time in the intervention-rivaroxaban group compared to placebo. 2) Secondary major events endpoints including but not necessary limited to: - Death (all cause mortality). - MACE (Major Adverse Cardiovascular Events): myocardial infarction, stroke, cardiovascular death. - MALE (Major Adverse Limb Events) e.g. acute og chronic critical limb ischaemia and including amputation above the ankle. - Transient ischaemic attack (TIA) - Major b
Interventions
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| More hyperechoic carotid plaques in the intervention group, with 1 year rivaroxaban treatment, compared to placebo over time determined by increase in plaque echogenicity with at least 20 % in grey-median-scale (GSM) registered by ultrasound, as an expression of plaque stabilizaton by rivaroxaban. | — |
Secondary
| Measure | Time frame |
|---|---|
| volumen, thrombus volumen and intraplaque contrastfilling over time in the intervention-rivaroxaban group compared to placebo. 2) Secondary major events endpoints including but not necessary limited to: - Death (all cause mortality). - MACE (Major Adverse Cardiovascular Events): myocardial infarction, stroke, cardiovascular death. - MALE (Major Adverse Limb Events) e.g. acute og chronic critical limb ischaemia and including amputation above the ankle. - Transient ischaemic attack (TIA) - Major b | — |
Countries
Denmark
Outcome results
None listed