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| Name | Class |
|---|---|
| VU University of Amsterdam | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prescribing a statin | Experimental | Newly prescribing a statin |
|
| Not prescribing a statin | No Intervention | Not prescribing a statin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Statin (atorvastatin, fluvastatin, pravastatin, rosuvastatin or simvastatin) | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 3, 6, 12, 18, 24 (and 36) months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Renske van den Berg, Prof. dr. | Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands | Principal Investigator |
| Nathalie van der Velde, Prof. dr. | Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41070271 | Derived | 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. |
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The SAFEST database can be requested by other researchers. These requests will be reviewed according the requirements for sharing SAFEST data.
After data-collection/analysis.
Requirements for sharing SAFEST data include:
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Multicentre prospective randomized open-label approach with blinded end-points evaluation (PROBE)
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|
|
| 1 and 2 years |
| Number of falls | Falls, measured using the falls calender. Participant returns the fall calender every 3 months. | 1 and 2 years |
| Time to first fall | Falls, measured using the falls calender. Participant returns the fall calender every 3 months. | 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. | 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) | 1 and 2 years |
| Cardiovascular Risk Status | method of assessing is to be decided. | 1 and 2 years |
| Principal Investigator |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
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| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| D000069059 | Atorvastatin |
| D000077340 | Fluvastatin |
| D017035 | Pravastatin |
| D000068718 | Rosuvastatin Calcium |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D008148 | Lovastatin |
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