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Aspirin Resistance and Stroke Risk: Platelet Function Analysis in Patients With Ischemic Events

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ClinicalTrials.gov Identifier: NCT01586975
Recruitment Status : Completed
First Posted : April 27, 2012
Results First Posted : December 3, 2015
Last Update Posted : December 31, 2015
Information provided by (Responsible Party):
Northwestern University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Stroke
Myocardial Infarctions
Interventions: Drug: Clopidogrel
Drug: Aspirin 81 mg
Drug: Aspirin >300 mg

  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 with cerebrovascular disease and taking one or more antiplatelet medication were consented for study participation from 2007 though 2010. Patients were recruiting on the inpatient stroke unit at Northwestern Memorial Hospital and seen in the outpatient stroke clinic.

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

Reporting Groups
Clopidogrel 75 mg Clopidogrel 75 mg QD
Aspirin 81 mg Aspirin 81 mg QD
Aspirin > 300 mg Aspiring > 300 mg QD

Participant Flow:   Overall Study
    Clopidogrel 75 mg   Aspirin 81 mg   Aspirin > 300 mg
STARTED   15   32   46 
COMPLETED   15   32   46 
NOT COMPLETED   0   0   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
Clopidogrel 75 mg Clopidogrel 75 mg QD
Aspirin 81 mg Aspirin 81 mg QD
Aspiring >300 mg Aspirin >300 mg QD
Total Total of all reporting groups

Baseline Measures
   Clopidogrel 75 mg   Aspirin 81 mg   Aspiring >300 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   32   46   93 
Age, Customized 
[Units: Years]
Mean (Full Range)
 (37 to 83) 
 (36 to 93) 
 (21 to 87) 
 (21 to 93) 
[Units: Participants]
Female   9   16   26   51 
Male   6   16   20   42 
Race (NIH/OMB) 
[Units: Participants]
American Indian or Alaska Native   0   0   0   0 
Asian   0   2   2   4 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   2   4   7   13 
White   13   25   37   75 
More than one race   0   0   0   0 
Unknown or Not Reported   0   1   0   1 
Region of Enrollment 
[Units: Participants]
United States   15   32   46   93 

  Outcome Measures

1.  Primary:   PFA1   [ Time Frame: 3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months) ]

  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
No text entered.

  More Information

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: Northwestern University
Organization: Northwestern University
phone: 312.503.4394
e-mail: r-bernstein@northwestern.edu


Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT01586975     History of Changes
Other Study ID Numbers: Aspirin Resistance and Stroke
IRB#0996-007 FUND#7810 ( Other Identifier: Northwestern Memorial Hospital )
First Submitted: August 3, 2011
First Posted: April 27, 2012
Results First Submitted: June 29, 2015
Results First Posted: December 3, 2015
Last Update Posted: December 31, 2015