NCT00268762

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

September 19, 2012

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

7.5 years

First QC Date

December 20, 2005

Results QC Date

August 20, 2012

Last Update Submit

November 3, 2014

Conditions

Ischemic Stroke

Keywords

strokethrombin inhibitionthrombolysisbleedingoutcome

Outcome Measures

Primary Outcomes (1)

  • Symptomatic and Radiographic Intracerebral Hemorrhage

    Significant intracerebral hemorrhage as defined by either: 1. Symptomatic intracerebral hemorrhage or 2. Parenchymal hematoma type 2.

    Within 7 days of enrollment

Secondary Outcomes (2)

  • Arterial Complete Recanalization at 2 Hours Post tPA Bolus

    2 hours complete recanalization post tPA bolus

  • Arterial Complete Recanalization at 24 Hours Post tPA Bolus

    24 hours from tPA bolus

Study Arms (1)

Intervention

EXPERIMENTAL

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

Drug: argatroban

Interventions

argatrobanDRUG

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

Intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Alabama-Birmingham

Birmingham, Alabama, 35249, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

University of Texas-Southwestern Dallas

Dallas, Texas, 75390, United States

Location

Memorial Hermann Hospital-Medical Center

Houston, Texas, 77030, United States

Location

Memorial Hermann Southwest Hospital

Houston, Texas, 77074, United States

Location

Related Publications (2)

  • 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.

    PMID: 16908730RESULT

  • 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.

    PMID: 22223235RESULT

MeSH Terms

Conditions

Ischemic StrokeStrokeHemorrhage

Interventions

argatroban

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Possible selection bias and investigators unblinded to treatment. In addition, although 60/65 patients had 24 hour recanalization data, only 47 were available at 2 hours.

Results Point of Contact

Title
Andrew D. Barreto, MD
Organization
University of Texas Health Science Center at Houston
andrew.d.barreto@uth.tmc.edu
713-500-7002

Study Officials

  • Andrew D. Barreto, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor - Neurology

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 22, 2005

Study Start

February 1, 2003

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

November 10, 2014

Results First Posted

September 19, 2012

Record last verified: 2014-11

Locations

US(6)