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Trial record 20 of 1261 for:    ASPIRIN AND Platelet Aggregation

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
Sponsor:
Information provided by (Responsible Party):
Northwestern University

Tracking Information
First Submitted Date  ICMJE August 3, 2011
First Posted Date  ICMJE April 27, 2012
Results First Submitted Date  ICMJE June 29, 2015
Results First Posted Date  ICMJE December 3, 2015
Last Update Posted Date December 31, 2015
Study Start Date  ICMJE July 2007
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2015)
PFA1 [ Time Frame: 3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months) ]
Platelet Function Analysis (PFA) lab results: PFA was performed using the PFA 100 device (Dade-Behring), which uses a higher sheer stress flow cytometry paradigm to measure the time in seconds to closing of an aperture. Normal is defined as <172 seconds."
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2012)
  • PFA results correlating with ischemic events and bleeding complications [ Time Frame: 4 years ]
    Platelet Function Analysis (PFA) lab results, and P2y12 lab results
  • PFA results correlating with ischemic events and bleeding complications [ Time Frame: 4 years ]
    Platelet Function Analysis (PFA) lab results, and P2y12 lab results. If there is a change in the lab results that show the chosen agent (ie aspirin or clopidogrel) is not working, then the agent will be modified.
Change History Complete list of historical versions of study NCT01586975 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin Resistance and Stroke Risk: Platelet Function Analysis in Patients With Ischemic Events
Official Title  ICMJE Multiphase Study to Determine if Platelet Function Analysis Results Correlate With Ischemic Events and Bleeding Complications
Brief Summary The purpose of this study is to determine if PFA results correlate with ischemic event outcomes as well as bleeding complications. Hypothesis is antiplatelet agents will be more efficacious if they are administered in a dose-adjusted manner using PFA results as a guide.
Detailed Description Atherothrombotic disease is a leading killer of adults throughout the world. The current mainstay for the prevention of ischemic vascular events is the use of aspirin Antiplatelet agents are used routinely for the primary and secondary prevention of vascular events in patients with a prior history of stroke, TIA, or at high risk for the development of cerebrovascular disease. Numberous individual studies and meta-analyses have shown that essentially all of the oral antiplatelet agents have limited efficacy, with relative risk reductions in the range of 20-35%. The purpose of this study is to perform serial platelet function assays (PFAs) on patients with cerebrovascular disease who are taking antiplatelet agents and perform a pilot study to determine the feasibility of administering ASA as a dose adjusted medication using PFA. The long term goal of this study is to determine whether antiplatelet therapy will be more efficacious and/or safer if it is administered in a dose-adjusted manner.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Myocardial Infarctions
Intervention  ICMJE
  • Drug: Clopidogrel
    Clopidogrel 75 mg QD
    Other Name: Plavix
  • Drug: Aspirin 81 mg
    Aspirin 81mg QD
    Other Names:
    • Acetylsalicylic Acid
    • ASA
  • Drug: Aspirin >300 mg
    Aspirin >300 mg QD
    Other Names:
    • Acetylsalicylic Acid
    • ASA
Study Arms  ICMJE
  • Active Comparator: Clopidogrel 75 mg
    Clopidogrel 75 mg daily
    Intervention: Drug: Clopidogrel
  • Active Comparator: Aspirin 81 mg
    open-label Aspirin 81 mg daily
    Intervention: Drug: Aspirin 81 mg
  • Active Comparator: Aspirin > 300mg
    open-label Aspirin over 300 mg daily
    Intervention: Drug: Aspirin >300 mg
Publications * Taylor TN, Davis PH, Torner JC, Holmes J, Meyer JW, Jacobson MF. Lifetime cost of stroke in the United States. Stroke. 1996 Sep;27(9):1459-66. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2015)
93
Original Actual Enrollment  ICMJE
 (submitted: April 26, 2012)
133
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient must be taking Aspirin or Plavix
  • Patient must have had a stroke, TIA or cerebrovascular disease

Exclusion Criteria:

-None

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01586975
Other Study ID Numbers  ICMJE Aspirin Resistance and Stroke
IRB#0996-007 FUND#7810 ( Other Identifier: Northwestern Memorial Hospital )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark J Alberts, MD Northwestern University
PRS Account Northwestern University
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP