COAST Study - Cholesterol Optimization After Stroke

NCT07256171 | Not Yet Recruiting

• 1 other identifier: 8247
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stroke (CVA) or Transient Ischemic Attack; Cerebral Hemorrhage

Keywords

LDL cholesterol; lipid-lowering agents; statins; ezetimibe; bempedoic acid; PCSK9 inhibitors; stroke; cerebral hemorrhage; transient ischemic attack

Outcome Measures

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.

  3 months

Secondary Outcomes (5)

• Proportion of patients achieving an LDL target value

  3 months

• Recurrence of stroke (ischemic or hemorrhagic), TIA, or acute cardiovascular events

  3 months

• All-cause mortality

  3 months

• Adverse events related to lipid-lowering medications

  3 months

• Functional disability

  3 months

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be included with any etiological subtype of ischemic stroke (e.g., cardioembolic, atherosclerotic, lacunar, etc.) or hemorrhagic stroke or TIA.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Cerebral Hemorrhage

Interventions

Diet, Fat-Restricted; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Ezetimibe; 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; PCSK9 Inhibitors; Fibric Acids

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Serine Proteinase Inhibitors; Protease Inhibitors; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Giovanni Frisullo, MD, PhD

CONTACT

0630156321; giovanni.frisullo@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11