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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00624000
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : November 8, 2011
Genentech, Inc.
Information provided by (Responsible Party):
Susan Wilson, University of North Carolina, Chapel Hill

Brief 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 stroke study protocol, i.e. randomized within 3 hours of onset of symptoms of ischemic stroke then treated within 3 hours in the IV Activase arm and within 4 hours in the IA Activase arm.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: IV tpa (Alteplase) vs IA tpa (Alteplase) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IV vs. IA tPA (Activase) in Acute Ischemic Stroke With CTA Evidence of Major Vessel Occlusion
Study Start Date : March 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Arm Intervention/treatment
Experimental: 1
IA administration of Alteplace vs. IV administration of Alteplace
Drug: IV tpa (Alteplase) vs IA tpa (Alteplase)
Alteplase was administered Either IA or IV x 1

Active Comparator: 2
IA administration of Alteplase vs.IV administration of Alteplase
Drug: IV tpa (Alteplase) vs IA tpa (Alteplase)
Alteplase was administered Either IA or IV x 1

Primary Outcome Measures :
  1. Feasibility of enrolling 12 subjects with major vessel occlusion within 1 year and random 1:1 assignment to treatment with IV (N=6) and IA (N=6) IA Activase using the following criteria: Time to clinical and radiological assessments [ Time Frame: 3 years ]
  2. Time to IA Activase treatment [ Time Frame: 3 years ]
  3. Preliminary safety assessment: 24 hour symptomatic ICH [ Time Frame: 3 years ]
  4. Resources utilized and risk-benefit of IA Activase treatment. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. 90-day efficacy outcome including NIHSS, modified Rankin Scale and Barthel's Index. [ Time Frame: 3 years ]
  2. 24-h recanalization (TIMI 2/3) on MRA or CTA [ Time Frame: 3 years ]
  3. Major extracranial bleed (defined under section 3.3.3) and asymptomatic intracranial hemorrhage. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:Subjects will be eligible if the following criteria are met:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  • Age > 18 years
  • NIHSS ≥ 4 or isolated aphasia or isolated hemianopsia

Exclusion Criteria:

  • NIHSS >30
  • Coma
  • Rapidly improving symptoms
  • History of stroke in the last 6 weeks
  • Seizure at onset
  • Subarachnoid Hemorrhage (SAH ) or suspected SAH
  • Any history of Intracrannial Hemorrhage (ICH)
  • Neoplasm
  • Septic embolism
  • Surgery, biopsy, trauma or LP in last 30 days
  • Head trauma in the last 90 days
  • Bleeding diathesis, or INR >1.7 or PTT >1.5 times baseline or platelet <100K
  • SBP >180 or DBP ≥100 despite treatment with 3 doses of IV Labetalol (10-20 mg Q10")
  • Lacunar stroke syndrome
  • CT: Hemorrhage, tumor (except small meningioma), significant mass effect, midline shift, acute hypodensity or >1/3 MCA territory sulcal effacement
  • Radiological contrast hypersensitivity
  • Angiographic: Dissection, lack of access, lack of occlusion, or nonatherosclerotic arteriopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00624000

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United States, North Carolina
University of North Carolina Stroke Center
Chapel Hill, North Carolina, United States, 27599-7025
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Genentech, Inc.
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Principal Investigator: Souvik Sen, MD University of North Carolina
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Susan Wilson, Sub-Investigator, University of North Carolina, Chapel Hill Identifier: NCT00624000    
Other Study ID Numbers: BB-IND # 11364
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011
Keywords provided by Susan Wilson, University of North Carolina, Chapel Hill:
Ischemic Stroke
Additional relevant MeSH terms:
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Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action