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Argatroban Stroke Treatment - A Pilot Safety Study

Information source: The University of Texas Health Science Center, Houston
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ischemic Stroke

Intervention: argatroban (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: The University of Texas Health Science Center, Houston

Official(s) and/or principal investigator(s):
Andrew D. Barreto, MD, Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Symptomatic and Radiographic Intracerebral Hemorrhage

Secondary outcome:

Arterial Complete Recanalization at 2 Hours Post tPA Bolus

Arterial Complete Recanalization at 24 Hours Post tPA Bolus

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.

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- 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

Locations and Contacts

University of Alabama-Birmingham, Birmingham, Alabama 35249, United States

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States

Tulane University, New Orleans, Louisiana 70112, United States

University of Texas-Southwestern Dallas, Dallas, Texas 75390, United States

Memorial Hermann Hospital-Medical Center, Houston, Texas 77030, United States

Memorial Hermann Southwest Hospital, Houston, Texas 77074, United States

Additional Information

Introduction of the staff and facility of the stroke team, explanation of stroke, types of strokes, treatment, risk factors, recovery, clinical trials, and contact information.

Starting date: February 2003
Last updated: November 3, 2014

Page last updated: August 20, 2015

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