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Stroke Interventions in Clinical Trials
Printable Version
Tissue plasminogen activator
Activase® Alteplase, tPA

Action
Thrombolytic

Status
US FDA approved in acute ischemic stroke within 3 hours of onset, June 1996. Study of tPA with stroke onset 3-5 hours (ATLANTIS) halted 7/98 due to lack of efficacy.

Trial(s)
  = Ongoing
  = Completed

Abciximab and rt-PA in Acute Ischemic Stroke Treatment
ALIAS - Pilot Albumin in Acute Stroke
ARTIS Antiplatelet therapy in combination with Recombinant t-PA Thrombolysis in Ischemic Stroke.
ARTIST + AMPA Receptor Antagonist Treatment in Ischemic Stroke Trial
ATLANTIS Alteplase ThromboLysis for Acute Noninterventional Therapy in Ischemic Stroke
ATTRACT Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
CASES Canadian Activase for Stroke Effectiveness Study
CLEAR IVH Evaluating Accelerated Resolution of Intraventricular Hemorrhage, rt-PA (Cathflo®) Treatment of Brain Hemorrhage
CLEAR Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke [SPOTRIAS]
CLEAR-ER Study of the Combination Therapy of rt-PA and Eptifibatide to Treat Acute Ischemic Stroke[SPOTRIAS].
Clinical importance of microbleeds in patients receiving IV thrombolysis
CLOTBUST Phase I Combined Lysis of Thrombus in Brain ischemia with Transcranial Ultrasound and Systemic TPA [SPOTRIAS]
CLOTBUST Phase II Combined Lysis of Thrombus in Brain Ischemia with Transcranial Ultrasound and Systemic TPA [SPOTRIAS]
CLOTBUSTER A Randomized, Active Controlled, Double-Blinded Trial of the Combined Lysis of Thrombus With Ultrasound, Microspheres and Systemic Tissue Plasminogen Activator (tPA) for Emergent Revascularization (CLOTBUSTER) in Acute Ischemic Stroke
COAST-II Cooling in acute Stroke-II
Comparison of Intra-arterial and Intravenous Thrombolysis for Ischemic Stroke with Hyperdense Middle Cerebral Artery Sign
DEFUSE Diffusion-weighted Imaging Evaluation For Understanding Stroke Evolution
DITCH Dutch Intraventricular Thrombolysis after Cerebral Hemorrhage study
ECASS-I European Cooperative Acute Stroke Study
ECASS-II European and Australian Cooperative Stroke Study II
ECASS-III ECASS-III: Placebo controlled trial of alteplase (rt-PA) in acute ischemic hemispheric stroke where thrombolysis is initiated between 3 and 4 hours after stroke onset
EMS Emergency Management of Stroke Bridging Trial
EPITHET - Pilot Echoplanar Imaging Thrombolysis Evaluation - Pilot Study
EPITHET Echoplanar Imaging Thrombolysis Evaluation Trial
EXTEND Extending the Time for Thrombolysis in Emergency Neurological Deficits
ICTuS-L Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke [SPOTRIAS]
IMS - II Interventional Management of Stroke Study
IMS - III The Interventional Management of Stroke (IMS) III Trial
IMS Interventional Management of Stroke Study
Intraoperative, intracisternal tissue plasminogen activator for the prevention of vasospasm
IST-3 Third International Stroke Trial
ITAIS-II Imaging-based Thrombolysis trial in Acute Ischemic Stroke-II
ITAIS Imaging-based Thrombolysis Trial in Acute Ischemic Stroke
ITT Intraventricular Hemorrhage Thrombolysis Trial
MAGIC BIOLOGICAL MARKERS AS PREDICTORS OF CLINICAL-FUNCTIONAL OUTCOME AND RESPONSE TO REVASCULARIZATION STRATEGIES IN ACUTE ISCHEMIC STROKE
Multi MERCI Mechanical Embolus Removal in Cerebral Ischemia
NINDS-tPA NINDS t-PA Stroke Trial
Perfusion-CT guided intravenous thrombolysis at 3 to 6 hours: feasibility and safety study
Pilot randomized trial of tissue plasminogen activator in acute ischemic stroke
Prevention of delayed ischemic deficits after aneurysmal subarachnoid hemorrhage by intrathecal bolus injection of tissue plasminogen activator
Safety and Efficacy of MRI-Based Thrombolysis in Unclear-Onset Stroke
SITS-ISTR Safe Implementation of Thrombolysis in Stroke International Stroke Thrombolysis Register
SITS-MOST Safe Implementation of Thrombolysis in Stroke Monitoring Study
SLEUTH Safety of Lysis with EKOS Ultrasound in the Treatment of Intracerebral and Intraventricular Hemorrhage
STARS Standard Treatment with Alteplase to Reverse Stroke study
START-EXTEND STroke imAging pRevention and Treatment-Extending the time for Thrombolysis in Emergency Neurological Deficits
Study of Aspirin and TPA in Acute Ischemic Stroke
Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B)[SPOTRIAS]
TARTS Argatroban tPA Stroke Study [SPOTRIAS]
TELESTROKE TRUST_tPA: Therapeutic Trial Evaluating Efficacy of Telemedicine (TELESTROKE) of Patients With Acute Stroke
TESPI Thrombolysis in Elderly Stroke Patients in Italy
TRUMBI Transcranial Low-Frequency Ultrasound Mediated Thrombolysis in Brain Ischemia Study
TRUST Ultrasound Enhanced Thrombolytic Therapy of Middle Cerebral Artery Occlusion
TTAISS Thrombolytic Therapy in Acute Ischemic Stroke Study, Part A
Urokinase versus r-TPA in Stroke Patients

Web Links and Publications
Note: This is an abridged publications list. Click on a clinical trial name above for a full list of publications resulting from that trial.

Thrombolytic Agents, Systemic Patient Information (MEDLINEplus).

DEFUSE Study Web Site

EPITHET Web Site

Intraventricular rt-PA in Patients with Intraventricular Hemorrhage.
ClinicalTrials.gov

Genentech Web Site.

Overview of Cochrane thrombolysis meta-analysis.
Neurology. 2001;57(5 Suppl 2):S69-76. Review.

CLOTBUST: design of a randomized trial of ultrasound-enhanced thrombolysis for acute ischemic stroke.
J Neuroimaging. 2004 Apr;14(2):108-12.

Ultrasound-enhanced thrombolysis for acute ischemic stroke: phase I. Findings of the CLOTBUST trial.
J Neuroimaging. 2004 Apr;14:113-7.

Ultrasound-enhanced thrombolysis for stroke: clinical significance.
Eur J Ultrasound. 2002 Nov;16(1-2):131-40.

Intravenous tissue-type plasminogen activator for treatment of acute stroke: the Standard Treatment with Alteplase to Reverse Stroke (STARS) study.
JAMA 2000 Mar 1;283(9):1189-91.

The rtPA (alteplase) 0- to 6-hour acute stroke trial, part A (A0276g) : results of a double-blind, placebo-controlled, multicenter study. Thromblytic therapy in acute ischemic stroke study investigators.
Stroke 2000 Apr;31(4):811-6.

Recombinant tissue-type plasminogen activator (Alteplase) for ischemic stroke 3 to 5 hours after symptom onset. The ATLANTIS Study: a randomized controlled trial.
JAMA 1999 Dec 1;282(21):2019-26

Intravenous thrombolysis with recombinant tissue plasminogen activator for acute hemispheric stroke. The European Cooperative Acute Stroke Study.
JAMA 1995 Oct 4;274(13):1017-25

Urgent therapy for stroke. Part I. Pilot study of tissue plasminogen activator administered within 90 minutes.
Stroke 1992 May;23(5):632-40.

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