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Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)

This study has been terminated.
(The recruitment into DIAS4 has been stopped as the result of DIAS 3 indicates that the study is unlikely to reach its primary endpoint with the current protocol)
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00856661
First received: March 5, 2009
Last updated: February 8, 2017
Last verified: February 2017
Results First Received: October 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Stroke
Interventions: Drug: Desmoteplase
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Desmoteplase 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
Placebo Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset

Participant Flow:   Overall Study
    Desmoteplase   Placebo
STARTED   135 [1]   135 [1] 
Treated   126   131 
Randomized Not Treated   9   4 
COMPLETED   108   106 
NOT COMPLETED   27   29 
Death                15                18 
Protocol Violation                2                1 
Withdrawal by Subject                1                2 
Lost to Follow-up                1                3 
Physician Judgement                8                5 
[1] Randomised



  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
Desmoteplase Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
Placebo Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
Total Total of all reporting groups

Baseline Measures
   Desmoteplase   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 135   135   270 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.1  (11.1)   68.2  (12.5)   68.6  (11.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      72  53.3%      69  51.1%      141  52.2% 
Male      63  46.7%      66  48.9%      129  47.8% 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   111   115   226 
Black or african americal   11   9   20 
Asian   7   6   13 
Other   6   5   11 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Modified Rankin Scale Score (mRS) (Percentage of Participants With mRS Scores 0-2)   [ Time Frame: Day 90 ]

2.  Secondary:   National Institutes of Health Stroke Scale (NIHSS) Score. (Percentage of Participants With NIHSS Scores <=1 or NIHSS Decrease >=8)   [ Time Frame: 90 days ]

3.  Secondary:   Composite of mRS & NIHSS Response (Percentage of Participants With mRS Scores 0-2 and (NIHSS <= 1 or NIHSS Decrease >= 8)   [ Time Frame: Day 90 ]

4.  Secondary:   Modified Ranking Scale Score (Using the Ordinal Scale)   [ Time Frame: Day 90 ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: study director
Organization: H. Lundbeck A/S
e-mail: LundbeckClinicalTrials@Lundbeck.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00856661     History of Changes
Other Study ID Numbers: 12649A
2008-005539-14 ( EudraCT Number )
Study First Received: March 5, 2009
Results First Received: October 6, 2015
Last Updated: February 8, 2017