Clinical trial • Phase III • Neurology

ATORVASTATIN for Ischemic stroke|Transient ischemic attack

Phase III trial of ATORVASTATIN for Ischemic stroke|Transient ischemic attack.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Ischemic stroke|Transient ischemic attack
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
19-08-2024
First CTIS Authorization Date
10-12-2024

Trial design

Randomised, initiation of statin therapy (usual care; licensed statins such as atorvastatin 10 mg, rosuvastatin 5 mg, fluvastatin 20 mg, pravastatin 10 mg, simvastatin 40 mg administered according to their licences) versus no statin therapy (no statin).-controlled Phase III trial across 23 sites in Netherlands.

Randomised
Yes
Comparator
Initiation of statin therapy (usual care; licensed statins such as Atorvastatin 10 mg, Rosuvastatin 5 mg, Fluvastatin 20 mg, Pravastatin 10 mg, Simvastatin 40 mg administered according to their licences) versus no statin therapy (no statin).
Real World Control
Yes
Target Sample Size
600
Trial Duration For Participant
730

Eligibility

Recruits 600 The trial population are frail older individuals (age ≥70). 'isVulnerablePopulationSelected' is false in the CTIS record, however consent provisions allow involvement of a proxy: the exclusion criteria state 'Inability to respond to questions, either independently or with the assistance of a proxy.' and 'Inability or unwillingness to provide written informed consent, either independently or with the assistance of a proxy.' Participants must be able to communicate in Dutch (exclusion: 'Inability to communicate in Dutch')..

Vulnerable Population
The trial population are frail older individuals (age ≥70). 'isVulnerablePopulationSelected' is false in the CTIS record, however consent provisions allow involvement of a proxy: the exclusion criteria state 'Inability to respond to questions, either independently or with the assistance of a proxy.' and 'Inability or unwillingness to provide written informed consent, either independently or with the assistance of a proxy.' Participants must be able to communicate in Dutch (exclusion: 'Inability to communicate in Dutch').

Inclusion criteria

  • {"criterion_text":"- A recent ischemic stroke or TIA (within 6 weeks before inclusion)\n- Age equal to or greater than 70 years at the time of the ischemic stroke or TIA\n- Frailty, as defined by a pre-event score of 4-7 and/or a post-event score of 6-7 on the validated Clinical Frailty Scale\n- Not using statin therapy at the time of the index event"}

Exclusion criteria

  • {"criterion_text":"- Previous serious adverse drug reactions (defined as an adverse reaction that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitaliza-tion, results in persistent or significant disability or incapacity, or is a birth defect) to statins or other contraindications to statin use.\n- Very severe frailty or very limited life expectancy (< 6 months) as defined by a score >= 8 points on the validated Clinical Frailty Scale\n- Inability to communicate in Dutch\n- Inability to respond to questions, either independently or with the assistance of a proxy.\n- Inability or unwillingness to provide written informed consent, either independently or with the assistance of a proxy"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- \tMACE-free survival over a two-year period, measured at 3, 6, 12, 18, and 24 months, with additional follow-up at three years for those enrolled early in the recruitment phase.","definition_or_measurement_approach":"Measured at 3, 6, 12, 18 and 24 months (with additional follow-up at 3 years for early enrollees); endpoint is MACE-free survival over a two-year period."}
  • {"endpoint_text":"- \tHealth-Related Quality of Life (HRQoL) measured using the Patient-Reported Outcomes Measurement Information System - Global-10 (PROMIS-10) at 3, 6, 12, 18, and 24 months, with additional follow-up at three years for those enrolled early in the recruitment phase.","definition_or_measurement_approach":"Measured using PROMIS-10 at 3, 6, 12, 18 and 24 months (with additional follow-up at 3 years for early enrollees) to assess HRQoL."}

Secondary endpoints

  • {"endpoint_text":"- Number of new major cardiovascular events","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Cognitive function at 12 and 24 months.","definition_or_measurement_approach":"Assessed at 12 and 24 months."}
  • {"endpoint_text":"- Falls (number and time to first fall)","definition_or_measurement_approach":"Collected as number of falls and time to first fall."}
  • {"endpoint_text":"- Frailty status at 12 and 24 months.","definition_or_measurement_approach":"Frailty status assessed at 12 and 24 months."}
  • {"endpoint_text":"- Functional outcome at 12 and 24 months.","definition_or_measurement_approach":"Functional outcomes assessed at 12 and 24 months."}

Recruitment

Planned Sample Size
600
Recruitment Window Months
60
Consent Approach
Written informed consent required (Subject information and informed consent form listed: 'L1 SIS and ICF'). Consent may be provided independently or with the assistance of a proxy as referenced in the exclusion criteria ('Inability or unwillingness to provide written informed consent, either independently or with the assistance of a proxy'). Participants must be able to communicate in Dutch (exclusion: 'Inability to communicate in Dutch'). No age-specific consent documents are indicated in the CTIS record (participants are aged ≥70).

Methods

  • Recruitment at participating hospital sites in the Netherlands (site list provided in CTIS trialSites).
  • Use of study flyer (documents listed: 'L2 Flyer SAFEST-RCT' and 'E3 Flyer SAFEST RCT versie 2').
  • Formal recruitment procedure documented ('K1 Recruitment procedure SAFEST-RCT' listed among documents).

Geography

Total Number Of Sites
23
Total Number Of Participants
600

Netherlands

Earliest CTIS Part Ii Submission Date
25-11-2024
Latest Decision Or Authorization Date
17-12-2025
Processing Time Days
387
Number Of Sites
23
Number Of Participants
600

Sites

Site Name
Sint Franciscus Vlietland Groep Stichting
Department Name
Neurologie
Contact Person Name
Kirsten Dorresteijn
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Neurologie
Contact Person Name
Nyika Kruyt
Contact Person Email
n.d.kruyt@lumc.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Neurologie
Contact Person Name
Julie Staals
Contact Person Email
j.staals@mumc.nl
Site Name
Zuyderland Medisch Centrum Stichting
Department Name
Neurologie
Contact Person Name
Tobien Schreuder
Contact Person Email
t.schreuder@zuyderland.nl
Site Name
Isala Klinieken Stichting
Department Name
Neurologie
Contact Person Name
Wilmar Jolink
Contact Person Email
w.m.t.jolink@isala.nl
Site Name
Maasstad Ziekenhuis Stichting
Department Name
Neurologie
Contact Person Name
Walid Moudrous
Site Name
Frisius MC
Department Name
Neurology
Contact Person Name
Frank van Rooij
Contact Person Email
frank.van.rooij@znb.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Neurology
Contact Person Name
Bart van der Worp
Contact Person Email
H.B.vanderWorp@umcutrecht.nl
Site Name
Medisch Spectrum Twente
Department Name
Neurologie
Contact Person Name
Renate Arntz
Contact Person Email
ResearchOC@mst.nl
Site Name
Catharina Ziekenhuis Stichting
Department Name
Neurologie
Contact Person Name
Inge van Uden
Site Name
UMC Groningen
Department Name
Neurologie
Contact Person Name
Suzanne Persoon
Contact Person Email
s.persoon@umcg.nl
Site Name
Stichting OLVG
Department Name
Neurologie
Contact Person Name
Renske van den Berg-Vos
Contact Person Email
r.vandenberg-vos@olvg.nl
Site Name
Jeroen Bosch Ziekenhuis Stichting
Department Name
Neurologie
Contact Person Name
Marian van Zagten
Contact Person Email
m.v.zagten@jbz.nl
Site Name
St. Antonius Ziekenhuis
Department Name
Neurology
Contact Person Name
Marjon van der Meulen
Contact Person Email
m.meulen@antoniusziekenhuis.nl
Site Name
Gelre Hospitals
Department Name
Neurology
Contact Person Name
Renske Wieberdink
Contact Person Email
R.Wieberdink@gelre.nl
Site Name
Flevoziekenhuis Stichting
Department Name
Neurologie
Contact Person Name
Elizabeth Osei
Site Name
Haaglanden Medisch Centrum Stichting
Department Name
Neurology
Contact Person Name
Raoul Kloppenborg
Contact Person Email
r.kloppenborg@haaglandenmc.nl
Site Name
Stichting Elisabeth-Tweesteden Ziekenhuis
Department Name
Neurology
Contact Person Name
Ben Jansen
Contact Person Email
wetenschapsbureau@etz.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Neurologie
Contact Person Name
Sarah Vermeer
Contact Person Email
svermeer@rijnstate.nl
Site Name
Elkerliek Ziekenhuis
Department Name
Neurologie
Contact Person Name
Maaike Bos
Contact Person Email
mm.bos@elkerliek.nl
Site Name
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Department Name
Neurologie
Contact Person Name
Floris de Kleermaeker
Contact Person Email
fdkleermaeker@viecuri.nl
Site Name
Erasmus Medisch Centrum 1
Department Name
Neurologie
Contact Person Name
Heleen den Hertog
Contact Person Email
mdenhertoch@erasmusmc.nl
Site Name
Amsterdam UMC Stichting
Department Name
Neurology
Contact Person Name
Paul Nederkoorn
Contact Person Email
p.j.nederkoorn@amsterdamumc.nl

Sponsor

Primary sponsor

Full Name
Amsterdam UMC Stichting
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Third parties

  • {"country":"","full_name":"ZonMw","duties_or_roles":"Monetary support","organisation_type":""}

Investigational products

Investigational Product Name
Atorvastatine Viatris 10 mg Filmtabletten
Active Substance
ATORVASTATIN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Starting Dose
10 mg
Dose Levels
10 mg (film-coated tablet)
Maximum Dose
80 mg
Investigational Product Name
Fluvastatine 20 mg PCH, capsules
Active Substance
FLUVASTATIN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Starting Dose
20 mg
Dose Levels
20 mg (capsule)
Maximum Dose
80 mg
Investigational Product Name
Rosuvastatine Viatris 5 mg Filmtabletten
Active Substance
ROSUVASTATIN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Starting Dose
5 mg
Dose Levels
5 mg (film-coated tablet)
Maximum Dose
80 mg
Investigational Product Name
Pravastatine Viatris 10 mg Tabletten
Active Substance
PRAVASTATIN SODIUM
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Starting Dose
10 mg
Dose Levels
10 mg (tablet)
Maximum Dose
80 mg
Investigational Product Name
Simvastatine Mylan 40 mg, filmomhulde tabletten
Active Substance
SIMVASTATIN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Starting Dose
40 mg
Dose Levels
40 mg (film-coated tablet)
Maximum Dose
80 mg

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