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Randomized Controlled Trial of Argatroban With Tissue Plasminogen Activator (tPA) for Acute Stroke (ARTSS-2)

This study has been terminated.
(The study was halted prematurely at 90 of 105 planned patients due to the beneficial results of embolectomy clinical trials.)
Sponsor:
Collaborator:
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Andrew D. Barreto, MD, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01464788
First received: November 1, 2011
Last updated: March 31, 2017
Last verified: March 2017
Results First Received: January 26, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Outcomes Assessor;   Primary Purpose: Treatment
Condition: Ischemic Stroke
Interventions: Drug: Low Dose Argatroban
Drug: High Dose Argatroban
Drug: rt-PA (alteplase)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients who have had an ischemic stroke and admitted to the Accident and Emergency Department or Acute Stroke Unit by their treating physician receive IV Recombinant tissue plasminogen activator as per standard treatment, provided they are able to be treated within 4.5 hours of the onset of their stroke symptoms.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who met the inclusion criteria received a head CT scan prior to initiation of rt-PA and the Argatroban infusion. If available, patients also underwent intracranial vessel imaging performed before or immediately after IV-tPA bolus (but before Argatroban bolus). Patients could not be randomized until after the CTA demonstrated an occlusion.

Reporting Groups
  Description
Low-dose Argatroban + Rt-PA (Alteplase)

100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours.

and

Intravenous rt-PA (alteplase) 0.9mg/kg (max dose 90mg); 10% bolus and remaining over 1 hour.

High Dose Argatroban + Rt-PA (Alteplase)

Argatroban: 100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours.

and

Intravenous rt-PA (alteplase) 0.9mg/kg (max dose 90mg); 10% bolus and remaining over 1 hour.

Rt-PA (Alteplase) Only Intravenous rt-PA (alteplase) 0.9mg/kg (max dose 90mg); 10% bolus and remaining over 1 hour.

Participant Flow:   Overall Study
    Low-dose Argatroban + Rt-PA (Alteplase)   High Dose Argatroban + Rt-PA (Alteplase)   Rt-PA (Alteplase) Only
STARTED   30   31   29 
COMPLETED   30   29   29 
NOT COMPLETED   0   2   0 
Lost to Follow-up                0                1                0 
Patient had hemorrhage after tPA started                0                1                0 



  Baseline Characteristics
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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
Low Dose Argatroban + Rt-PA 100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
High Dose Argatroban + Rt-PA 100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
Rt-PA (Alteplase) rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
Total Total of all reporting groups

Baseline Measures
   Low Dose Argatroban + Rt-PA   High Dose Argatroban + Rt-PA   Rt-PA (Alteplase)   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   31   29   90 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      11  36.7%      13  41.9%      13  44.8%      37  41.1% 
>=65 years      19  63.3%      18  58.1%      16  55.2%      53  58.9% 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.9  (15.1)   67.1  (13.4)   68.9  (15.4)   68.9  (14.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      13  43.3%      15  48.4%      12  41.4%      40  44.4% 
Male      17  56.7%      16  51.6%      17  58.6%      50  55.6% 
Region of Enrollment 
[Units: Participants]
       
United States   22   22   21   65 
United Kingdom   8   9   8   25 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With 0 or 1 on Modified Rankin Scale   [ Time Frame: 90 days ]

2.  Primary:   Number of Participants With Symptomatic Intracranial Hemorrhage Within 48 Hours of tPA Administration   [ Time Frame: 48-hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Study limitations include the open-label design that was necessary due to prohibitive costs of placebo manufacture and sham aPTT tests. Given that vessel imaging was not mandatory, a meaningful analysis of early recanalization rates was not possible.


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


Results Point of Contact:  
Name/Title: Dr. Andrew Barreto
Organization: McGovern Medical School UTHealth - Houston
phone: 713-500-7002
e-mail: andrew.d.barreto@uth.tmc.edu


Publications:

Responsible Party: Andrew D. Barreto, MD, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01464788     History of Changes
Other Study ID Numbers: HSC-MS-11-0464
Study First Received: November 1, 2011
Results First Received: January 26, 2017
Last Updated: March 31, 2017