COAST Study - Cholesterol Optimization After Stroke
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Recent acute cerebrovascular event, defined as a confirmed diagnosis of ischemic stroke, hemorrhagic stroke, or TIA occurring less than 30 days prior to enrollment.
Availability of a baseline measured LDL cholesterol value (direct or calculated) at the time of the index event or close to it.
Patients for whom, in routine clinical practice, a lipid-lowering therapy has been indicated and prescribed for secondary prevention (low-fat diet, supplements, statins, ezetimibe, bempedoic acid, PCSK9 inhibitors, fibrates, or other lipid-lowering agents).
Written informed consent obtained and signed by the patient before inclusion. If the patient is unable to provide consent autonomously (e.g., due to aphasia, impaired consciousness, etc.), informed consent will be obtained from a legal representative or proxy, in accordance with applicable regulations.
Disqualifiers
• Comorbidities or conditions preventing 3-month follow-up: e.g., terminal oncological disease with life expectancy <3 months, severe cognitive impairment (e.g., advanced dementia), or other conditions that make it impossible to obtain follow-up information; inability to contact the patient after discharge (e.g., non-resident foreign patient or lacking telephone contacts).
Any other clinical, psychological, or social condition that, in the investigator's judgment, may compromise the patient's ability to adhere to the study or the reliability of the collected data.
Trial population
Patients will be included with any etiological subtype of ischemic stroke (e.g., cardioembolic, atherosclerotic, lacunar, etc.) or hemorrhagic stroke or TIA.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Adherence to lipid-lowering therapy
Adherence to lipid-lowering therapy, defined as the percentage of patients who are adherent (intake of ≥80% of prescribed doses) and persistent (on therapy without interruptions) at the end of follow-up. Rates of persistence (patients who did not discontinue therapy) and adherence (patients who took it regularly) may also be considered separately.
Time frame
3 monthsSecondary outcomes
1
Proportion of patients achieving an LDL target value
Proportion of patients achieving an LDL target value (for example, \<55 mg/dL for ischemic stroke patients, \<40 mg/dL for patients already on maximal therapy, etc.) at the 90 ± 15-day follow-up. This endpoint reflects the overall effectiveness of lipid-lowering management in bringing patients to the recommended target.
Time frame
3 months2
Recurrence of stroke (ischemic or hemorrhagic), TIA, or acute cardiovascular events
Recurrence of stroke (ischemic or hemorrhagic), TIA, or acute cardiovascular events (myocardial infarction or angina) within 90 ± 15 days of the index event (composite endpoint). The incidence of recurrent ischemic stroke, hemorrhagic stroke, and TIA will also be analyzed separately as secondary individual endpoints.
Time frame
3 months3
All-cause mortality
All-cause mortality at 90 ± 15 days. In parallel, cerebrovascular mortality (deaths attributable to the direct consequences of stroke or other cerebrovascular events) will be analyzed relative to mortality from other causes.
Time frame
3 months4
Adverse events related to lipid-lowering medications
Adverse events related to lipid-lowering medications: incidence of clinically relevant side effects reported within 90 ± 15 days (e.g., myalgias without significant CK elevation, gastrointestinal disturbances from fibrates, injection-site reactions with PCSK9 inhibitors, etc.). These will contribute to the overall evaluation of therapy tolerability.
Time frame
3 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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