Clinical trial NCT06785727: StAtins in Frail OldEr Patients with Ischemic Stroke or Transient Ischemic Attack - the Randomized Controlled Trial
Official title: StAtins in Frail OldEr Patients with Ischemic Stroke or Transient Ischemic Attack - the Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Ischemic Stroke
Transient Ischemic Attack
Keywords: statin
ischemic stroke
transient ischemic attack
quality of life
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
First posted: 2025-01-21
Enrollment: 612
Sex: ALL
Minimum age (years): 70
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentre prospective randomized open-label approach with blinded end-points evaluation (PROBE)
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.\[49\]

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Health-Related Quality of Life (HrQoL)
timeFrame: 3, 6, 12, 18, 24 (and 36) months.
measure: Major Adverse Cardiovascular Events (MACE) free survival
timeFrame: 3, 6, 12, 18, 24 (and 36) months.
Secondary outcomes:
measure: Functional Outcome
timeFrame: 1 and 2 years
measure: Cognition MoCA
timeFrame: 1 and 2 years
measure: Number of falls
timeFrame: 1 and 2 years
measure: Time to first fall
timeFrame: 2 years
measure: General quality of life EuroQol Questionnaire (EQ-5D-5L)
timeFrame: 1 and 2 years
measure: Societal costs
timeFrame: 1 and 2 years
measure: Cardiovascular Risk Status
timeFrame: 1 and 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
name: Renske van den Berg, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
name: Nathalie van der Velde, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: