Authorised Therapeutic use (Phase IV) Ischemic stroke and transient ischemic attack

StAtins in Frail oldEr patients with ischemic Stroke or Transient ischemic attack – The Randomized Controlled Trial

EU CTIS ID: 2024-517343-31-00

What this study is testing

To evaluate the effect of initiating statin therapy versus no statin therapy on Major Adverse Cardiovascular Events (MACE)-free survival and health-related quality of life (HRQoL) over a two-year follow-up in frail individuals aged 70 and above with a recent ischemic stroke or TIA.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • A recent ischemic stroke or TIA (within 6 weeks before inclusion)
  • Age equal to or greater than 70 years at the time of the ischemic stroke or TIA
  • 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
  • Not using statin therapy at the time of the index event

You likely can't join if

  • 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.
  • 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.