Statins in Frail Older Patients with Ischemic Stroke or Transient Ischemic Attack - the Prospective Cohort Study

NCT06785740 | Recruiting

• 1 other identifier: 2024.0202
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

Brief Summary

Two Dutch guidelines (Stroke and Cardiovascular Risk Management) provide conflicting advice on optimal statin treatment in older patients. In the SAFEST-cohort, the investigators will assess the impact of continuing versus discontinuing 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.

Conditions

Ischemic Stroke; TIA

Outcome Measures

Primary Outcomes (2)

• 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. months.

  3, 6, 12, 18, 24 (and 36) months

• Major Adverse Cardiovascular Events (MACE) free survival

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

  3, 6, 12, 18, 24 (and 36) months

Secondary Outcomes (7)

• Functional outcome

  3, 6, 12, 18, 24 months

• Cognition

  3, 6, 12, 18, 24 months

• Number of falls

  3, 6, 12, 18, 24 months

• Time to first fall

  3, 6, 12, 18, 24 months

• General quality of life using the EQ-5D-5L

  3, 6, 12, 18, 24 months

Study Arms (2)

Statin continued

Patients in which the statin was continued after the index event

Drug: Statin

Statin discontinued

Patients in which the statin was discontinued after the index event

Interventions

Statin DRUG

Statin use

Also known as: atorvastatin, rosuvastatin, pravastatin, simvastatin, fluvastatin

Statin continued

Eligibility Criteria

• Age: 70 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

frail individuals aged 70 and above with a recent ischemic stroke or transient ischemic attack (TIA)

You may qualify if:

• age = 70 years or older at the time of ischemic stroke or TIA;
• already 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 Scale.

You may not qualify if:

• Previous serious adverse drug reactions (defined as an adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisa-tion, results in persistent or significant disability or incapacity, or is a birth defect32) 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.
• Inability or unwillingness to provide written informed consent, either independently or with the assistance of a proxy.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• VU University of Amsterdam: collaborator

Study Sites (4)

Flevoziekenhuis

Almere Stad, Netherlands

RECRUITING

Amsterdam UMC, location AMC

Amsterdam, Netherlands

RECRUITING

Catharina Ziekenhuis

Eindhoven, Netherlands

RECRUITING

Isala Klinieken

Zwolle, Netherlands

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium; Pravastatin; Simvastatin; Fluvastatin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Lovastatin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Renske van den Berg-Vos, 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanna R Prins, MSc

CONTACT

0031 20 566 9111; s.r.prins@amsterdamumc.nl

Birgit A Damoiseaux-Volman, PhD

CONTACT

0031 20 566 9111; b.a.damoiseaux@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor dr. Nathalie van der Velde, Full Professor Geriatric medicine (internal medicine)

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: January 21, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: January 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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 be anonymously shared * data can only be used to study the research question for which participants signed the ICF * data will not be shared for commercial purposes.

Locations

NL (4)