A Phase 4 interventional study of Statin (atorvastatin, fluvastatin, pravastatin, rosuvastatin or simvastatin) in Ischemic Stroke and Transient Ischemic Attack, sponsored by Prof. dr. Nathalie van der Velde. Not yet recruiting. Open to participants aged 70 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-01-21.
Sponsored by Prof. dr. Nathalie van der Velde · Phase 4, Interventional, and Prevention
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.
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 612 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →This is the only study on the registry with Prof. dr. Nathalie van der Velde as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Newly prescribing a statin
Drug: Statin (atorvastatin, fluvastatin, pravastatin, rosuvastatin or simvastatin)
Not prescribing a statin
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).
Also known as: Lipitor, Lescol XL, Crestor, Zocor
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.
Time frame: 3, 6, 12, 18, 24 (and 36) months.
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.
Time frame: 3, 6, 12, 18, 24 (and 36) months.
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).
Time frame: 1 and 2 years
Cognition MoCA
will be measured using the Montreal Cognitive Assessment (MoCA)51 or the Telephone version of the MoCA (T-MOCA)
Time frame: 1 and 2 years
Number of falls
Falls, measured using the falls calender. Participant returns the fall calender every 3 months.
Time frame: 1 and 2 years
Time to first fall
Falls, measured using the falls calender. Participant returns the fall calender every 3 months.
Time frame: 2 years
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.
Time frame: 1 and 2 years
Societal costs
Societal costs measured by The Older Persons and Informal Caregivers Survey - Minimum Data Set (TOPICS-MDS) (questions 23 - 37)
Time frame: 1 and 2 years
Cardiovascular Risk Status
method of assessing is to be decided.
Time frame: 1 and 2 years
No study locations are listed for this record.
Plan to share: Yes — The SAFEST database can be requested by other researchers. These requests will be reviewed according the requirements for sharing SAFEST data.
Supporting information: Study protocol, Statistical analysis plan
Time frame: After data-collection/analysis.
Access criteria: Requirements for sharing SAFEST data include: privacy laws of the Netherlands, policy of NFU and AmsterdamUMC must be followed data will anonymously data can only be used to study the research question for which participants signed the ICF data will not be shared for commercial purposes.
No publications or documents are linked to this record.
Start is estimated for Feb 2025; primary completion for Dec 2028, 46 months later.
Of 74 non-industry phase 4 interventional studies under Ischemic Stroke, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 41. This study's planned 46 months is above that.
Counting every sponsor, half of 83 studies reached it within 31 months; a quarter within 24 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Statins