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Argatroban Stroke Treatment - A Pilot Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00268762
Recruitment Status : Completed
First Posted : December 22, 2005
Results First Posted : September 19, 2012
Last Update Posted : November 10, 2014
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Ischemic Stroke
Intervention: Drug: argatroban

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Date of first enrollment: May 6, 2003 Date of last enrollment: August 20, 2010 All patients enrolled through hospital emergency departments

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intervention Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target partial thromboplastin time (PTT) of 1.75 times the patient's baseline.

Participant Flow:   Overall Study
    Intervention
STARTED   65 
COMPLETED   65 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intervention Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target PTT of 1.75 times the patient's baseline.

Baseline Measures
   Intervention 
Overall Participants Analyzed 
[Units: Participants]
 65 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   34 
>=65 years   31 
Age 
[Units: Years]
Mean (Standard Deviation)
 63  (14) 
Gender 
[Units: Participants]
 
Female   36 
Male   29 
Region of Enrollment 
[Units: Participants]
 
United States   65 


  Outcome Measures

1.  Primary:   Symptomatic and Radiographic Intracerebral Hemorrhage   [ Time Frame: Within 7 days of enrollment ]

2.  Secondary:   Arterial Complete Recanalization at 2 Hours Post tPA Bolus   [ Time Frame: 2 hours complete recanalization post tPA bolus ]

3.  Secondary:   Arterial Complete Recanalization at 24 Hours Post tPA Bolus   [ Time Frame: 24 hours from tPA bolus ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Andrew D. Barreto, MD
Organization: University of Texas Health Science Center at Houston
phone: 713-500-7002
e-mail: andrew.d.barreto@uth.tmc.edu


Publications of Results:

Responsible Party: Andrew Barreto, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00268762     History of Changes
Other Study ID Numbers: Argatroban+TPA 02-121B
P50NS44227 project #2 ( Other Grant/Funding Number: P50NS44227 )
First Submitted: December 20, 2005
First Posted: December 22, 2005
Results First Submitted: August 20, 2012
Results First Posted: September 19, 2012
Last Update Posted: November 10, 2014