Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial

Summary

A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor ischemic strokes (with an NIH Stroke Scale \[NIHSS\] score less than or equal to 3).

TIAs are common \[25\], and are often harbingers of disabling strokes. Approximately 250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8 years \[32\], there are approximately 2.4 million TIA survivors. In a national survey, one in fifteen of those over 65 years old reported a history of TIA \[33\], which is equivalent to a prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed transient neurological events, the true incidence of TIA may be twice as high as the rates of diagnosis \[33\]. Based on our review of the National Inpatient Sample for 1997-2003, there were an average of 200,000 hospital admissions for TIA each year, with annual charges climbing quickly in the period to $2.6 billion in 2003.

Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death at 90 days.

Conditions

• Ischemic Attack, Transient

Interventions

DRUG

Clopidogrel

Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days

DRUG

placebo

Loading dose of 8 tablets followed by one tablet daily for 89 days

Sponsors & Collaborators

• Neurological Emergencies Treatment Trials Network (NETT)

  collaborator NETWORK

• Medical University of South Carolina

  collaborator OTHER

• The Emmes Company, LLC

  collaborator INDUSTRY

• University of California, San Francisco

  lead OTHER

Principal Investigators

• S. Claiborne Johnston, MD, PhD · University of Texas - Austin

• J. Donald Easton, MD · University of California, San Francisco

• Anthony S. Kim, MD, MAS · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-28

Primary Completion

2018-04-09

Completion

2018-04-09

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• Finland
• France
• Germany
• Mexico
• New Zealand
• Spain
• United Kingdom

Study Locations