AzTrials
AzTrials

Ischemic StrokePhase 1/2NCT00268762

Argatroban Stroke Treatment - A Pilot Safety Study

A Phase 1/2 study testing argatroban in people with Ischemic Stroke, run by The University of Texas Health Science Center, Houston at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Is the combination of low doses of argatroban in combination with rt-PA safe, and does it increase recanalization in patients with acute ischemic stroke. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Ischemic Stroke
What is being tested?
argatroban
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
6 sitesUnited States
Study dates
Feb 2003to Aug 2010
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ischemic stroke symptoms with onset ≤ 3 hours*.
  • *or<4.5 hours according to local standard of care. Symptoms must be distinguished from another ischemic event such as syncope, seizure, migraine, and hypoglycemia. If the patient reports awakening with the event, the time of onset should be considered as last time the patient (or a witness to the patient's condition) considered herself/himself normal.
  • 18-85 years of age.
  • A clot causing complete or partial occlusion (TIBI 0, 1, 2, or 3) via TCD in any one of the following areas: distal iternal carotid artery (ICA), Meddle cerebral artery (MCA - M1 or M2), posterior cerebral arteral (ICA - P1 or P2), distal vertebral or basilar occlusions. TCD must be abnormal prior to the start of Argatroban. For patients without temporal windows (or in centers without emergent access to TCD), an abnormal CTA is required for enrollment (TIMI 0 or 1).
  • Females of childbearing potential must have a negative serum pregnancy test prior administration of argatroban.
  • Signed informed consent by the patient or the patient's legal representative.
  • Meet criteria for rt-PA therapy.

Who cannot join

  • Evidence of intracranial hemorrhage on baseline CT scan or non-vascular cause of neurologic deficit.
  • National institute health stroke scale (NIHSS) Level of Consciousness score ≥2.
  • Baseline (immediately pre-Argatroban) NIHSS ≤ 5 or patient with rapidly resolving deficit or rapidly improving symptoms consistent with TPA.
  • Baseline NIHSS ≥15 for right hemisphere strokes and ≥20 for left hemisphere strokes.
  • Pre-existing disability with modified rankin scale (mRS) ≥ 2.
  • CT scan findings of hypoattenuation of the x-ray signal (hypodensity)involving ≥ 1/2 of the MCA territory.
Show all 27Show fewer
  • Any evidence of clinically significant bleeding, or known coagulopathy.
  • Patients currently on warfarin, with an elevated INR ≥ 1.5.
  • Patients currently or within previous 48 hrs. on heparin with an elevated aPTT greater than the upper limit of normal.
  • Heparin flush required for an IV line. Line flushes with saline only.
  • History of ICH or significant bleeding episode within the 3 months before study enrollment.
  • Major surgery or serious trauma within the last 6 weeks.
  • Patients who have had an arterial puncture at a non-compressible site, biopsy of parenchymal organ, or lumbar puncture within the last 2 weeks.
  • Previous stroke, myocardial infarction, post myocardial infarction pericarditis, intracranial surgery, or significant head trauma within 3 months of baseline.
  • Uncontrolled hypertension.
  • Alcohol and/or substance abuse that would increase the risk of hemorrhage in the opinion of the investigator.
  • Surgical intervention anticipated within the next 7 days.
  • Hepatic dysfunction, defined by liver function tests greater than 3 times upper limit of normal at baseline, specifically serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT).
  • Abnormal blood glucose
  • History of primary or metastatic brain tumor.
  • Severe mental deficit prior to onset of stroke such as organic brain disorder, schizophrenia, etc.
  • Concurrent severe neurologic disorder, such as seizure at onset of stroke or uncontrolled seizure disorder that complicates diagnosis of acute ischemic stroke.
  • Current platelet count< 100,000/mm3.
  • Life expectancy <3 months in the opinion of the investigator.
  • Need to be on concomitant (i.e, during the Argatroban infusion) anticoagulants other than Argatroban, including any form of heparin, unfractionated heparin (UFH), low molecular weight heparin (LMWH), defibrinogenating agent, dextran, other direct thrombin inhibitors or thrombolytic agents, glycoprotein llb/llla (GPIIb/IIIa) or warfarin.(Caveat: If these anticoagulants can be deferred for 48 hours, then they can be included).
  • Participated in investigational study within 30 days before the first dose of study medication.
  • Hypersensitivity to Argatroban or its agents

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of Alabama-Birmingham

    Birmingham, Alabama, 35249

  • University of Texas-Southwestern Dallas

    Dallas, Texas, 75390

  • Memorial Hermann Hospital-Medical Center

    Houston, Texas, 77030

  • Memorial Hermann Southwest Hospital

    Houston, Texas, 77074

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Tulane University

    New Orleans, Louisiana, 70112

Other trials in United States

About this study

Official title: A Pilot Study To Determine The Safety Of Argatroban Injection In Combination With Tissue Plasmingen Activator (TPA) In Patients With Acute Ischemic Stroke

Is the combination of low doses of argatroban in combination with rt-PA safe, and does it increase recanalization in patients with acute ischemic stroke.

Read the detailed description

All patients with acute ischemic stroke who qualify for IV rt-PA under accepted guidelines, and who have an occluded middle cerebral artery documented on TCD, receive standard dose IV rt-PA and a bolus and 48 hour infusion of argatroban aimed at prolonging the aPTT 1.75 X baseline. Follow up CT scanning and TCD every 30 minutes for 2 hours and then daily will determine the incidence of hemorrhage, recanalization and reocclusion, and serial neurological exam will determine the clinical outcome. For patients without temporal windows, a baseline CT-Angiogram (CTA) demonstrating arterial occlusion can also be enrolled. In those patients, a follow-up CTA (24-36 hours) will be performed.

Conditions
Ischemic Stroke
Being tested
argatroban
Keywords
stroke, thrombin inhibition, thrombolysis, bleeding, outcome
Medical subject headings
Ischemic Stroke, Stroke, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • argatrobanDrug

    Argatroban IV Infusion at 1mcg/kg/min for 48 hours.

Study groups in NCT00268762
Study groupRoleWhat they receive
InterventionExperimentalArgatroban IV Infusion 1 mcg/kg/min for 48 hours
Receives: Drug: argatroban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptomatic and Radiographic Intracerebral Hemorrhage

    Significant intracerebral hemorrhage as defined by either:

    1. Symptomatic intracerebral hemorrhage or
    2. Parenchymal hematoma type 2.

    Measured: Within 7 days of enrollment

Secondary outcomes (2)

  1. Arterial Complete Recanalization at 2 Hours Post tPA Bolus

    Complete Recanalization as measured by either transcranial Doppler Ultrasound at 2 hours post tPA bolus.

    Measured: 2 hours complete recanalization post tPA bolus

  2. Arterial Complete Recanalization at 24 Hours Post tPA Bolus

    Complete recanalization at 24 hours post tPA bolus as measured by either transcranial Doppler ultrasound or CT-Angiography.

    Measured: 24 hours from tPA bolus

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2005 (estimated)
  2. Study startFeb 2003
  3. Primary completionAug 2010
  4. Study completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00268762
Sponsor's protocol ID
Argatroban+TPA 02-121B
Other IDs
P50NS44227 project #2, P50NS044227
Status last verified
Nov 2014
First submitted
20 Dec 2005
Last updated
10 Nov 2014
Data monitoring committee
Yes

Publications

  • Sugg RM, Pary JK, Uchino K, Baraniuk S, Shaltoni HM, Gonzales NR, Mikulik R, Garami Z, Shaw SG, Matherne DE, Moye LA, Alexandrov AV, Grotta JC. Argatroban tPA stroke study: study design and results in the first treated cohort. Arch Neurol. 2006 Aug;63(8):1057-62. doi: 10.1001/archneur.63.8.1057.

    PubMed 16908730

  • Barreto AD, Alexandrov AV, Lyden P, Lee J, Martin-Schild S, Shen L, Wu TC, Sisson A, Pandurengan R, Chen Z, Rahbar MH, Balucani C, Barlinn K, Sugg RM, Garami Z, Tsivgoulis G, Gonzales NR, Savitz SI, Mikulik R, Demchuk AM, Grotta JC. The argatroban and tissue-type plasminogen activator stroke study: final results of a pilot safety study. Stroke. 2012 Mar;43(3):770-5. doi: 10.1161/STROKEAHA.111.625574. Epub 2012 Jan 5.

    PubMed 22223235

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing argatroban in people with Ischemic Stroke, run by The University of Texas Health Science Center, Houston at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptomatic and Radiographic Intracerebral Hemorrhage (time frame: Within 7 days of enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00268762, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in