COAST Study - Cholesterol Optimization After Stroke
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study ID
- NCT07256171
- Status
- Not Yet Recruiting
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Conditions
- Cerebral Hemorrhage
- Stroke (CVA) or Transient Ischemic Attack
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- low-fat diet, supplements, statins, ezetimibe, bempedoic acid, PCSK9 inhibitors, fibrates, or other lipid-lowering agents — DRUGLow-Fat Diet Typical components: Increased fruits, vegetables, whole grains, lean proteins, and limited fried or processed foods. Supplements Non-prescription substances that can help reduce cholesterol, often used alongside diet or drugs. Plant sterols/stanols: Reduce cholesterol absorption in the intestine. Statins The first-line pharmacological treatment for high cholesterol. Mechanism: Inhibit HMG-CoA reductase, the key enzyme in cholesterol synthesis in the liver. Ezetimibe A cholesterol absorption inhibitor. Mechanism: Blocks intestinal absorption of dietary and biliary cholesterol. Bempedoic Acid A newer oral lipid-lowering drug. Mechanism: Inhibits ATP-citrate lyase, an enzyme upstream of HMG-CoA reductase in the cholesterol synthesis pathway. PCSK9 Inhibitors Monoclonal antibodies or siRNA therapies given by injection every 2-4 weeks (or biannually for inclisiran). Fibrates Drugs that primarily lower triglycerides and can modestly raise HDL cholesterol.
Study Details
This study (acronym COAST Trial) is a multicenter observational registry aiming to document: patients' adherence and persistence to lipid-lowering therapy prescribed for secondary prevention; the proportion of patients achieving LDL cholesterol therapeutic targets at 3 months; the incidence of cerebrovascular recurrence and mortality at 90 days, as well as the occurrence of any adverse effects from these therapies. This information will provide a snapshot of post-stroke/TIA lipid-lowering management across centers and identify areas for improvement, offering useful data to optimize secondary prevention strategies in everyday clinical practice.
Key Dates
- Start date
- Jan 1, 2026
- Status verified
- Nov 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 500 participants (estimated)
Primary Outcome Measure
Adherence to lipid-lowering therapy [ Time Frame: 3 months ]
Central Contacts
- Giovanni Frisullo, MD, PhD0630156321
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