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Challenges in acute ischemic stroke clinical trials.

Anthony J Furlan¹

¹University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH 44106, USA. anthony.furlan@uhhospitals.org

Current Cardiology Reports

|August 28, 2012

Summary

Acute ischemic stroke trials face challenges like short windows and patient variability. New imaging may identify salvageable brain tissue, improving future clinical trial design.

Area of Science:

Neurology
Clinical Trials
Stroke Research

Background:

Only three Phase III trials for acute ischemic stroke have been positive, all involving reperfusion therapies.
Intravenous tissue plasminogen activator (IV tPA) within 3 hours is the sole approved acute stroke treatment.
Numerous neuroprotective compounds show promise in animal models but have failed in human Phase III trials for acute ischemic stroke.

Purpose of the Study:

To address challenges in acute ischemic stroke clinical trial design.
To explore new methods for patient selection in stroke trials.
To improve the success rate of future acute stroke therapies.

Main Methods:

Review of past Phase III randomized clinical trials in acute ischemic stroke.

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Discussion of challenges including therapeutic window and stroke heterogeneity.

Exploration of novel imaging techniques for identifying salvageable brain tissue.

Consideration of insights from the 7 STAIR conferences on trial design.

Main Results:

The limited success of neuroprotective agents in Phase III trials highlights significant hurdles.
"Time is brain" and stroke heterogeneity are major challenges for acute stroke trials.
Premature trials, underpowered studies, and hemorrhage risks have hindered progress.
New imaging methods offer potential to overcome time-based limitations by identifying "tissue at risk".

Conclusions:

Acute ischemic stroke clinical trials require innovative designs to overcome persistent challenges.
Identifying patients with "salvageable brain" using advanced imaging may redefine eligibility criteria.
Future trial designs should incorporate advanced imaging and address stroke heterogeneity to improve therapeutic development.