EARLY 3-months Aggrenox Treatment Started Within 24 Hrs of Ischemic Stroke Onset vs. After One Week 100 mg ASA

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00562588
First received: July 6, 2007
Last updated: January 31, 2014
Last verified: January 2014
Results First Received: January 29, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: Cerebrovascular Accident
Interventions: Drug: Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg)
Drug: ASA 100 mg qd

  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
551 patients enrolled, 548 randomized, 543 treated; analysis is based on treated patients

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
Aspirin for 7 Days, Followed by Aggrenox ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
Aggrenox Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d

Participant Flow:   Overall Study
    Aspirin for 7 Days, Followed by Aggrenox     Aggrenox  
STARTED     260     283  
COMPLETED     168     184  
NOT COMPLETED     92     99  
Adverse Event                 40                 58  
Protocol Violation                 30                 26  
Lost to Follow-up                 12                 4  
Withdrawal by Subject                 10                 9  
unknown                 0                 2  



  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
Aspirin for 7 Days, Followed by Aggrenox ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
Aggrenox Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
Total Total of all reporting groups

Baseline Measures
    Aspirin for 7 Days, Followed by Aggrenox     Aggrenox     Total  
Number of Participants  
[units: participants]
  260     283     543  
Age  
[units: Years]
Mean ± Standard Deviation
  68.3  ± 11.5     66.5  ± 11.4     67.3  ± 11.5  
Gender  
[units: participants]
     
Female     95     109     204  
Male     165     174     339  



  Outcome Measures
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1.  Primary:   Telephone Modified Rankin Scale (Centralised, Blinded Assessment)   [ Time Frame: 90 days ]

2.  Secondary:   Change From Baseline in NIHSS (National Institutes of Health Stroke Scale)   [ Time Frame: Baseline and 90 days ]

3.  Secondary:   Patients With Relevant Event (Death, Non-fatal Stroke, Transient Ischaemic Attack (TIA), Myocardial Infarction (MI), Bleeding)   [ Time Frame: 90 days ]

4.  Secondary:   Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8   [ Time Frame: 8 days ]

5.  Secondary:   Change From Baseline in NIHSS (National Institutes of Health Stroke Scale) at Day 8   [ Time Frame: Baseline and 8 days ]

6.  Secondary:   Change of Special Biochemical Laboratory Value- CRP   [ Time Frame: 8 days ]

7.  Secondary:   Change of Special Biochemical Laboratory Value- MMP-9   [ Time Frame: 8 days ]

8.  Secondary:   Change of Special Biochemical Laboratory Value - MCP-1   [ Time Frame: 8 days ]

9.  Secondary:   Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 8   [ Time Frame: Baseline and day 8 ]

10.  Secondary:   Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 90.   [ Time Frame: Baseline and day 90 ]

11.  Secondary:   Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 8   [ Time Frame: Baseline and day 8 ]

12.  Secondary:   Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 90   [ Time Frame: Baseline and 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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00562588     History of Changes
Other Study ID Numbers: 9.182
Study First Received: July 6, 2007
Results First Received: January 29, 2010
Last Updated: January 31, 2014
Health Authority: Germany: BfArM (Bundesagentur fuer Arzneimittel und Medizinalprodukte)