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Ischemic StrokePhase 4SAFEST - RCTNCT06785727

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

A Phase 4 study testing Statin (atorvastatin, fluvastatin, pravastatin, rosuvastatin or simvastatin) in people with Ischemic Stroke and Transient Ischemic Attack, run by Prof. dr. Nathalie van der Velde.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 70 to 120 years
Conditions the study is for
Ischemic Stroke, Transient Ischemic Attack
What is being tested?
Statin (atorvastatin, fluvastatin, pravastatin, rosuvastatin or simvastatin)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
612 participants
Where
No sites listed yet
Study dates
1 Feb 2025to 1 Jul 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 to 120 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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]

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Birgit Damoiseaux-Volman, PhD contact

0031 20 566 9111

b.a.damoiseaux@amsterdamumc.nl

Susanna Prins, MSc contact

0031 20 566 9111

s.r.prins@amsterdamumc.nl

About this study

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.

Read the 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.

Being tested
Statin (atorvastatin, fluvastatin, pravastatin, rosuvastatin or simvastatin)
Keywords
statin, ischemic stroke, transient ischemic attack, quality of life
Medical subject headings
Ischemic Stroke, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Statin (atorvastatin, fluvastatin, pravastatin, rosuvastatin or simvastatin)Drug

    Also called Lipitor, Lescol XL, Crestor, Zocor

    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 products. They will be collected at the local pharmacy by the patient (following practice as usual).

Study groups in NCT06785727
Study groupRoleWhat they receive
Prescribing a statinExperimentalNewly prescribing a statin
Receives: Drug: Statin (atorvastatin, fluvastatin, pravastatin, rosuvastatin or simvastatin)
Not prescribing a statinNo interventionNot prescribing a statin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health-Related Quality of Life (HrQoL)

    This will be measured using the PROMIS-10 scale scores (ranging from 0 to 100, with higher scores indicating better health), including global mental health and global physical health subscales. Measurements at 3, 6, 12, 18, 24 (and 36) months.

    Measured: 3, 6, 12, 18, 24 (and 36) months.

  2. Major Adverse Cardiovascular Events (MACE) free survival

    Classical 3-point MACE (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) and non-cardiovascular death. Measurements at3, 6, 12, 18, 24 (and 36) months.

    Measured: 3, 6, 12, 18, 24 (and 36) months.

Secondary outcomes (7)

  1. Functional Outcome

    This will be assessed using the modified Rankin Scale (mRS) 49, with scores ranging from 0 to 6 (lower scores indicating better function).

    Measured: 1 and 2 years

  2. Cognition MoCA

    will be measured using the Montreal Cognitive Assessment (MoCA)51 or the Telephone version of the MoCA (T-MOCA)

    Measured: 1 and 2 years

  3. Number of falls

    Falls, measured using the falls calender. Participant returns the fall calender every 3 months.

    Measured: 1 and 2 years

  4. Time to first fall

    Falls, measured using the falls calender. Participant returns the fall calender every 3 months.

    Measured: 2 years

  5. General quality of life EuroQol Questionnaire (EQ-5D-5L)

    General QoL measure by EuroQol Questionnaire (EQ-5D-5L). This will be used to calculate the cost-effectiveness analysis (CAE). Possible scores range from 0-100, the higher, the better.

    Measured: 1 and 2 years

  6. Societal costs

    Societal costs measured by The Older Persons and Informal Caregivers Survey - Minimum Data Set (TOPICS-MDS) (questions 23 - 37)

    Measured: 1 and 2 years

  7. Cardiovascular Risk Status

    method of assessing is to be decided.

    Measured: 1 and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2025
  2. Study start1 Feb 2025 (estimated)
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicentre prospective randomized open-label approach with blinded end-points evaluation (PROBE)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
612 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06785727
Sponsor's protocol ID
2022-502059-79-00
Acronym
SAFEST - RCT
Status last verified
Jan 2025
First submitted
16 Jan 2023
Last updated
21 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The SAFEST database can be requested by other researchers. These requests will be reviewed according the requirements for sharing SAFEST data.

Publications

  • 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. 2025 Oct 5;7(2):e001297. doi: 10.1136/bmjno-2025-001297. eCollection 2025.

    PubMed 41070271

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Statin (atorvastatin, fluvastatin, pravastatin, rosuvastatin or simvastatin) in people with Ischemic Stroke and Transient Ischemic Attack, run by Prof. dr. Nathalie van der Velde.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Birgit Damoiseaux-Volman, PhD (0031 20 566 9111, b.a.damoiseaux@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-Related Quality of Life (HrQoL) (time frame: 3, 6, 12, 18, 24 (and 36) months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06785727, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2025.

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