StAtins in Frail OldEr Patients with Ischemic Stroke or Transient Ischemic Attack - the Randomized Controlled Trial

Обзор

Two Dutch guidelines (Stroke and Cardiovascular Risk Management) provide conflicting advice on optimal statin treatment in older patients. In the SAFEST - RCT, the investigators will assess the impact of starting versus not starting a statin in frail individuals aged 70 and above with a recent ischemic stroke or transient ischemic attack (TIA) on their health-related quality of life and Major Adverse Cardiovascular Events (MACE) free survival during a two-year follow-up period.

Подробное описание

Objective: To assess the impact of starting versus not starting a statin in frail individuals aged 70 and above with a recent ischemic stroke or transient ischemic attack (TIA) on their health-related quality of life and MACE free survival during a two-year follow-up period.

Study population: The patient population consists of frail older (\>=70 yrs) patients with a recent acute ischemic stroke or TIA who are admitted to the hospital or visit the outpatient clinic or emergency department for diagnostic evaluation, and who were not receiving statin treatment at the time of the acute event. Frailty is defined by a pre-event Clinical Frailty Scale (CFS) score of 4-7 and/or a post-event score of 6-7.

Description of intervention(s): Participants in the intervention group will start with a statin with target values following the Dutch stroke guideline. The control group will not start with a statin, aligning with the Dutch Cardiovascular Risk Management (CVRM) guideline recommendations.

Outcome measures:

This study has two co-primary endpoints: (1) Health-Related Quality of Life (HrQoL), using the Patient-Reported Outcomes Measurement Information System - Global-10 (PROMIS-10) and (2) Major Adverse Cardiovascular Events (MACE) free survival, after 2 years. We will evaluate these two co-primary outcomes at multiple time points, specifically at 3, 6, 12, 18, and 24 months. For patients enrolled in the beginning of recruitment, an extended follow-up of three years will be conducted to provide additional insights into the two primary endpoints.

Вмешательства

• Препарат Statin (atorvastatin, fluvastatin, pravastatin, rosuvastatin or simvastatin)
  The intervention group receives statin treatment following the current "Herseninfarct en Hersenbloeding" guideline. The intensity and target value of statin treatment are determined according to this national guideline. Which statin (atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin) will be selected and what dose will be prescribed is left to the discretion of the treating neurologist. The statins are registered in the Netherlands and use will be according to the licenses of the

Первичные конечные точки

• Health-Related Quality of Life (HrQoL) [Срок оценки: 3, 6, 12, 18, 24 (and 36) months.]
• Major Adverse Cardiovascular Events (MACE) free survival [Срок оценки: 3, 6, 12, 18, 24 (and 36) months.]

Вторичные конечные точки (7)

• Functional Outcome [Срок оценки: 1 and 2 years]
• Cognition MoCA [Срок оценки: 1 and 2 years]
• Number of falls [Срок оценки: 1 and 2 years]
• Time to first fall [Срок оценки: 2 years]
• General quality of life EuroQol Questionnaire (EQ-5D-5L) [Срок оценки: 1 and 2 years]
• Societal costs [Срок оценки: 1 and 2 years]
• Cardiovascular Risk Status [Срок оценки: 1 and 2 years]

Критерии участия

Критерии включения

• age = 70 years or older at the time of ischemic stroke or TIA;
• inclusion within 6 weeks after diagnosis of ischemic stroke or TIA;
• not using statin therapy at the time of the index event;
• frailty as defined by a pre-event score of 4-7 and/or post-event score of 6-7 on the validated Clinical Frailty Scfale.\[49\]

Критерии исключения

• Patients with a stroke or TIA of non-atherosclerotic etiology.
• Previous serious adverse drug reactions (defined as an adverse reaction that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect40) to statins or other contraindications to statin use.
• Very severe frailty or very limited life expectancy (< 6 months) as defined by a score >= 8 points on the validated Clinical Frailty Scale.
• Inability to communicate in Dutch.
• Inability to respond to questions, either independently or with the assistance of a proxy (a proxy is allowed to assist by writing on behalf of the participant in cases of physical incapacity or by discussing questions with the participant, but the proxy cannot make decisions for the participant).
• Inability or unwillingness to provide written informed consent, either independently or with the assistance of a proxy (a proxy is allowed to assist by writing on behalf of the participant in cases of physical incapacity or by discussing the consent form with the participant, but the proxy cannot make decisions or provide consent on behalf of the participant).
• Extremely high-risk patients, i.e. patients who have had two or more cardiovascular events within a period of one year.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Prins SR, Damoiseaux-Volman BA, Vermeer SE, Bossuyt PMM, Van Eekelen R, Bosmans JE, Van Poelgeest EP, Martens FMAC, Emmelot-Vonk MH, Verstraete E, Muller M, Moll Van Charante EP, Lindhout M, Van Der Velde N, Van Den Berg-Vos RM. Rationale and design of 'StAtins in Frail oldEr patients with ischemic Stroke or Transient ischemic attack-the Randomized Controlled Trial' (SAFEST-RCT). BMJ Neurol Open. PMID 41070271

Идентификаторы

NCT: NCT06785727 · 2022-502059-79-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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