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Argatroban TPA Stroke Study

Information source: The University of Texas Health Science Center, Houston
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Ischemic Stroke

Intervention: argatroban (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

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

Official(s) and/or principal investigator(s):
James C, Grotta, MD, Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston

Overall contact:
James C, Grotta, MD, Phone: 713-500-7088, Email: james.c.grotta@uth.tmc.edu

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 rt-PA In Patients With Acute Ischemic Stroke

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Symptomatic and radiographic intracerebral hemorrhage

Secondary outcome: arterial recanalization

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 control. 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.

Eligibility

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

Criteria:

Inclusion Criteria:

- Ischemic stroke symptoms with onset ≤ 3 hours.

- Males and females ages 18-85 years of age.

- A clot causing complete or partial occlusion via TCD in any one of the following

areas: distal ICA, MCA, PCA distal vertebral or basilar occlusions. TCD must be abnormal prior to the start of Argatroban. For patients without temporal windows, an abnormal CTA is required for enrollment(TIMI 0 or 1).

- Females of childbearing potential must have a negative serum pregnancy test prior to

the administration of trial medication.

- Signed written informed consent by the patient or the patient's legal representative

and/or guardian.

- Meet criteria for rt-PA therapy.

Exclusion Criteria:

- Evidence of intracranial hemorrhage on baseline CT scan or non-vascular cause of

neurologic deficit.

- 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 mRS ≥ 2.

- CT scan findings of hypoattenuation of the x-ray signal involving at least 2 lobes of

the brain an at least 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 SGOT and 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.

- Patients who, in the judgement of the investigator, need to be on concomitant (i. e,

during the Argatroban infusion) anticoagulants other than Argatroban, including any form of heparin, UFH, LMWH, defibrinogenating agent, dextran, other direct thrombin inhibitors or thrombolytic agents, GPIIb/IIIa or warfarin.(Caveat: However, if in the judgement of the investigator a patient needs to be anticoagulated, but this can be deferred for 48 hours, then they can be included).

- Currently participating or has participated in any investigational drug or device

study within 30 days before the first dose of study medication.

- Known hypersensitivity to Argatroban or its agents

Locations and Contacts

James C, Grotta, MD, Phone: 713-500-7088, Email: james.c.grotta@uth.tmc.edu

Memorial Hermann Hospital-Medical Center, Houston, Texas 77030, United States; Recruiting
James C. Grotta, MD, Phone: 713-500-7088, Email: james.c.grotta@uth.tmc.edu
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
Ending date: December 2009
Last updated: June 5, 2009

Page last updated: October 19, 2009

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