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 — DRUG
    Low-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

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