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Argatroban Stroke Treatment - A Pilot Safety Study

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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):
Andrew Barreto, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ischemic Stroke
Intervention Drug: argatroban
Enrollment 65

Recruitment Details Date of first enrollment: May 6, 2003 Date of last enrollment: August 20, 2010 All patients enrolled through hospital emergency departments
Pre-assignment Details  
Arm/Group Title Intervention
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 65
Completed 65
Not Completed 0
Arm/Group Title Intervention
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
<=18 years
0
   0.0%
Between 18 and 65 years
34
  52.3%
>=65 years
31
  47.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants
63  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Female
36
  55.4%
Male
29
  44.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 65 participants
65
1.Primary Outcome
Title Symptomatic and Radiographic Intracerebral Hemorrhage
Hide Description

Significant intracerebral hemorrhage as defined by either:

  1. Symptomatic intracerebral hemorrhage or
  2. Parenchymal hematoma type 2.
Time Frame Within 7 days of enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention
Hide Arm/Group Description:
Argatroban IV Infusion 1 mcg/kg/min for 48 hours
Overall Number of Participants Analyzed 65
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
6.2
(1.7 to 15.0)
2.Secondary Outcome
Title Arterial Complete Recanalization at 2 Hours Post tPA Bolus
Hide Description Complete Recanalization as measured by either transcranial Doppler Ultrasound at 2 hours post tPA bolus.
Time Frame 2 hours complete recanalization post tPA bolus
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention
Hide Arm/Group Description:
Argatroban IV Infusion 1 mcg/kg/min for 48 hours
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: percent of patients
40
3.Secondary Outcome
Title Arterial Complete Recanalization at 24 Hours Post tPA Bolus
Hide Description Complete recanalization at 24 hours post tPA bolus as measured by either transcranial Doppler ultrasound or CT-Angiography.
Time Frame 24 hours from tPA bolus
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention
Hide Arm/Group Description:
Argatroban IV Infusion 1 mcg/kg/min for 48 hours
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percent of patients
63
Time Frame 90 days during the study period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention
Hide Arm/Group Description 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.
All-Cause Mortality
Intervention
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intervention
Affected / at Risk (%) # Events
Total   21/65 (32.31%)    
Blood and lymphatic system disorders   
Significant laboratory abnormality   2/65 (3.08%)  2
Cardiac disorders   
Cardiac arrest   3/65 (4.62%)  3
General disorders   
Death  [1]  7/65 (10.77%)  7
Nervous system disorders   
Stroke progression or neurological worsening   5/65 (7.69%)  5
Significant intracerebral hemorrhage  [2]  4/65 (6.15%)  4
Cerebral edema   4/65 (6.15%)  4
Asymptomatic ICH   2/65 (3.08%)  2
Seizure   1/65 (1.54%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia/respiratory failure   3/65 (4.62%)  3
Skin and subcutaneous tissue disorders   
Angioedema   1/65 (1.54%)  1
Indicates events were collected by systematic assessment
[1]
Death that occured by any of the following causes: (brain herniation or respiratory failure)
[2]
Significant intracerebral hemorrhage defined as either: Symptomatic intracerebral hemorrhage or Parenchymal Hematoma - type 2
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Intervention
Affected / at Risk (%) # Events
Total   55/65 (84.62%)    
Blood and lymphatic system disorders   
Anemia/decrease in hemoglobin and hematocrit level   4/65 (6.15%)  5
Cardiac disorders   
Chest Pain   2/65 (3.08%)  2
Hypotension  [1]  3/65 (4.62%)  3
Tachycardia   7/65 (10.77%)  7
Patent Foramen Ovale  [2]  1/65 (1.54%)  1
Aortic valve vegetation   1/65 (1.54%)  1
Atrial Fibrillation   2/65 (3.08%)  2
Hypothermia   1/65 (1.54%)  1
Hypertension   3/65 (4.62%)  3
Endocrine disorders   
New diagnosis of diabetes mellitus   2/65 (3.08%)  2
Gastrointestinal disorders   
Nausea with or without Emesis   3/65 (4.62%)  3
General disorders   
Laboratory abnormalities - Chemistries  [3]  10/65 (15.38%)  14
Exacerbation of uterine prolapse   1/65 (1.54%)  1
Oral thrush   1/65 (1.54%)  1
Self extubation   1/65 (1.54%)  1
Laboratory Abnormalities - Electrolytes  [4]  13/65 (20.00%)  19
Laboratory Abnormalities - Elevated PTT >100 seconds   1/65 (1.54%)  1
Infections and infestations   
Fever   17/65 (26.15%)  17
Urinary Tract Infection   19/65 (29.23%)  19
Pneumonia   3/65 (4.62%)  3
Musculoskeletal and connective tissue disorders   
Minimally displaced fracture of base of fifth metacarpal   1/65 (1.54%)  1
Neck Pain   1/65 (1.54%)  1
Hand swelling   2/65 (3.08%)  2
Nervous system disorders   
Asymptomatic Intracranial Hemorhhage   13/65 (20.00%)  13
Agitation/lethargic/somnolent   2/65 (3.08%)  2
Stroke progression   2/65 (3.08%)  2
Neuro-worsening   3/65 (4.62%)  3
Psychiatric disorders   
Excessive sleepness   1/65 (1.54%)  1
Visual hallucination   1/65 (1.54%)  1
Restless   1/65 (1.54%)  1
Renal and urinary disorders   
Oliguria   1/65 (1.54%)  1
Urinary Retention   1/65 (1.54%)  1
Urinary Analysis laboratory abnormality  [5]  3/65 (4.62%)  3
Respiratory, thoracic and mediastinal disorders   
Right lung mass   1/65 (1.54%)  1
Coughing/gagging   1/65 (1.54%)  1
Both lung with rales   1/65 (1.54%)  1
Shortness of breath   1/65 (1.54%)  1
Pulmonary edema   1/65 (1.54%)  1
Hyperventilation   7/65 (10.77%)  7
Hypoventilation   1/65 (1.54%)  1
Skin and subcutaneous tissue disorders   
Rash   2/65 (3.08%)  2
Slight angioedema   1/65 (1.54%)  1
Indicates events were collected by systematic assessment
[1]
This includes one patient with "Low Blood Pressure"
[2]
New diagnosis of patent foramen ovale.
[3]
Elevated: Creatinine Kinase/troponin=6; Liver Function Tests=2; blood urea nitrogen (BUN)=1; myoglobin=1 ; Bilirubin=1; Ketones=1; Serum Creatinine=1; Hypoglycemia=1
[4]
Hypokalemia=5; Hyperkalemia=2; Hyponatremia=3; Hypernatremia=2; Hypocalcemia=3 Hypomagnesia=1; Hypophosphatemia=2; Electrolyte disorder not-specified=1
[5]
Leuko-Uria = 1 & Hematuria = 2
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.
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
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