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NCT00624000 · ClinicalTrials.gov registry record · NA

IV vs. IA tPA (Activase) in Acute Ischemic Stroke With CTA Evidence of Major Vessel Occlusion

A NA study of Ischemic Stroke, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
7
Enrollment target
1
Study location

NCT00624000 is a NA study of Ischemic Stroke that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 7 participants, below the 1,464-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00624000, a NA study of Ischemic Stroke, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
7 participants
Enrollment target
1
Study location

Study Summary

Stroke is the third leading cause of death in the United States, responsible for 158,488 deaths in 1998 (American Heart Association). Nationwide, each year, an estimated 600,000 to 750,000 people suffer a new or recurrent stroke. Cerebral infarction comprises 80% of all strokes and is the result of a complex series of cellular metabolic events that occur rapidly after interruption of blood flow to a region of the brain. The extent of the brain damage is dependent on the duration and severity of the cerebral ischemia. Acute thrombus formation or migration is the principal cause of blood flow interruption in at least 75% of cerebral infarctions. In several animal models of focal cerebral ischemia, restoration of cerebral blood flow within two to six hours after initial occlusion has been associated with smaller volumes of cerebral infarction and improved functional outcome. An effective way of dissolving the thrombus is by administration of recombinant tissue plasminogen activator or Activase (Alteplase, rt-PA), which promotes the proteolytic action of plasmin from plasminogen at the site of a clot. In this study, the drug, Activase, will be administered in subjects with acute ischemic stroke (AIS) intravenously (IV) or by local intra-arterial (IA) injection. The use of the intravenous administration within 3 hours of stroke symptom onset is FDA approved whereas the intra-arterial administration, despite evidence of potential benefit, is not currently FDA approved. Although not FDA approved, this study will evaluate the effectiveness of IA thrombolysis with Activase, used in AIS because of its higher rate of recanalization , potential expansion of the time window out to 6 hours, and lower doses of thrombolytic agent used compared with systemic or intravenous Activase. The study is designed to test the feasibility and provide preliminary safety data regarding the relative benefits and risks of IA Activase as compared to IV Activase when administered per the NINDS rt-PA

Conditions Studied

Interventions

  • DRUG IV tpa (Alteplase) vs IA tpa (Alteplase)

Study Locations (1)

North Carolina

  • University of North Carolina Stroke Center - Chapel Hill

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2004-03
Est. Completion 2008-12
Phase NA

What the Registry Record Tells You About NCT00624000

The ClinicalTrials.gov registry entry for NCT00624000 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,464-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (100% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Ischemic Stroke appearing as the primary indexed condition, and to 1 intervention - of which IV tpa (Alteplase) vs IA tpa (Alteplase) is the first listed.

NCT00624000 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT00624000 about?

NCT00624000 is a clinical study titled "IV vs. IA tPA (Activase) in Acute Ischemic Stroke With CTA Evidence of Major Vessel Occlusion". Stroke is the third leading cause of death in the United States, responsible for 158,488 deaths in 1998 (American Heart Association). Nationwide, each year, an estimated 600,000 to 750,000 people suffer a new or recurrent stroke. Cerebral infarction comprises 80% of all strokes and is the result of ...

What is the current status of trial NCT00624000?

This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2004-03. Estimated completion is 2008-12.

What conditions does trial NCT00624000 study?

This clinical trial studies the following conditions: Ischemic Stroke.

What interventions are being tested in trial NCT00624000?

The interventions under investigation include: IV tpa (Alteplase) vs IA tpa (Alteplase) (DRUG).

Who is sponsoring clinical trial NCT00624000?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00624000 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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