Overview
Sponsor-declared trial summary
Ischemic stroke or transient ischemic attack
To assess whether daily functioning and health related quality of life are better at two years when statins are stopped or not initiated, compared to when statins are used, in frail patients of >= 70 years with a recent ischemic stroke or transient ischemic attack.
Key facts
- Sponsor
- Amsterdam UMC
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2023-02-07
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- ZonMw
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To assess whether daily functioning and health related quality of life are better at two years when statins are stopped or not initiated, compared to when statins are used, in frail patients of >= 70 years with a recent ischemic stroke or transient ischemic attack.
Conditions and MedDRA coding
Ischemic stroke or transient ischemic attack
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Age = 70 years or older at the time of ischemic stroke or TIA; inclusion within 6 weeks after diagnosis of ischemic stroke or TIA; frailty as defined by a pre-event score of 4-7 and/or post-event score of 6-7 on the validated Clinical Frailty Scale.
Exclusion criteria 1
- Very severe frailty or very limited life expectancy (< 6 months) as defined by a score >= 8 points on the validated Clinical Frailty Scale; a previous serious adverse drug reaction to statins; not speaking Dutch; being unable to answer questions and have no proxy assessment available; being unable or not willing to give written informed consent (either patient or patient with help from proxy).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- (1) daily functioning, measured with the The Older Persons and Informal Caregivers Survey Short Form (TOPICS-SF), and (2) health related quality of life, measured using the PROMIS-10 with global mental health and global physical health summary scores, both at two years.
Secondary endpoints 1
- Secondary outcomes are daily functioning and hrQoL, both at one year. Other secondary outcomes are: physical functioning, functional outcome, cognition, emotional problems, falls, adverse drug events, cardiovascular risk status (based on clinical tests and lab results), general quality of life, societal costs, incidence of cardiovascular event recurrences and mortality - all at one and two years.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Atorvastatine Accord 10 mg filmomhulde tabletten
PRD5442511 · Product
- Active substance
- Atorvastatin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AA05 — ATORVASTATIN
- Marketing authorisation
- RVG 118716
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC
- Sponsor organisation
- Amsterdam UMC
- Address
- P. O. Box 7057
- City
- Amsterdam
- Postcode
- 1007 MB
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC
- Contact name
- SAFEST onderzoeksgroep
Public contact point
- Organisation
- Amsterdam UMC
- Contact name
- SAFEST onderzoeksgroep
Locations
1 EU/EEA country · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Not authorised | 1,200 | 17 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-13 | Netherlands | Not acceptable 2023-02-07
|
2023-02-07 |