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Trial record 59 of 1302 for:    ASPIRIN AND Platelet Aggregation

Reversibility of Dual Antiplatelet Therapy by Platelets

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ClinicalTrials.gov Identifier: NCT01248351
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : April 28, 2011
Sponsor:
Collaborators:
Novo Nordisk A/S
CSL Behring
Information provided by:
Medical University of Graz

Tracking Information
First Submitted Date  ICMJE November 19, 2010
First Posted Date  ICMJE November 25, 2010
Last Update Posted Date April 28, 2011
Study Start Date  ICMJE November 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2011)
Pharmacodynamic assessment of platelet function as assessed by 5 and 20 micromolar ADP [ Time Frame: 7 days ]
pharmacodynamic measurements of platelet function will be assessed at baseline, after 3 days administration of aspirin and clopidogrel (300 mg loading with aspirin and clopidogrel, maintenance with 100 mg aspirin and 75 mg clopidogrel, respectively) after retransfusion of stored platelets and 24 hours thereafter
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2010)
Pharmacodynamic assessment of platelet function as assessed by 5 and 20 mikromolar ADP [ Time Frame: 7 days ]
pharmacodynamic measurements of platelet function will be assessed at baseline, after 3 days administration of aspirin and clopidogrel (300 mg loading with aspirin and clopidogrel, maintenance with 100 mg aspirin and 75 mg clopidogrel, respectively) after retransfusion of stored platelets and 24 hours thereafter
Change History Complete list of historical versions of study NCT01248351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2010)
  • Pharmacodynamic assessment of platelet function as assessed by 20 mM arachidonic acid [ Time Frame: 7 days ]
    pharmacodynamic measurements of platelet function will be assessed at baseline, after 3 days administration of aspirin and clopidogrel (300 mg loading with aspirin and clopidogrel, maintenance with 100 mg aspirin and 75 mg clopidogrel, respectively) after retransfusion of stored platelets and 24 hours thereafter
  • Pharmacodynamic assessment of platelet function as assessed by Vasodilator stimulated phosphoprotein (VASP) phosphorylation (platelet reactivity index; PRI) [ Time Frame: 7 days ]
    pharmacodynamic measurements of platelet function will be assessed at baseline, after 3 days administration of aspirin and clopidogrel (300 mg loading with aspirin and clopidogrel, maintenance with 100 mg aspirin and 75 mg clopidogrel, respectively) after retransfusion of stored platelets and 24 hours thereafter
  • Pharmacodynamic assessment of platelet function as assessed by expression of GP IIb/IIIa receptors and P-selectin (Mean fluorescence intensity %) [ Time Frame: 7 days ]
    pharmacodynamic measurements of platelet function will be assessed at baseline, after 3 days administration of aspirin and clopidogrel (300 mg loading with aspirin and clopidogrel, maintenance with 100 mg aspirin and 75 mg clopidogrel, respectively) after retransfusion of stored platelets and 24 hours thereafter
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reversibility of Dual Antiplatelet Therapy by Platelets
Official Title  ICMJE Reversibility of Dual Antiplatelet Therapy by Platelets.Phase II Study
Brief Summary The objective of the study is to test the hypothesis whether or not autologous stored platelets are able to offset the antiplatelet effect of aspirin and clopidogrel as assessed by state-of-the-art platelet function assays.
Detailed Description

Dual antiplatelet therapy with aspirin and clopidogrel is a well established strategy to prevent thrombotic complications in patients with high platelet reactivity following plaque rupture in acute coronary syndromes (ACS) or percutaneous coronary interventions. Current practice guidelines for antiplatelet therapy advocate a one to 12 months dual antiplatelet therapy after bare metal stent PCI and a 12 months dual antiplatelet therapy after PCI in patients with ACS and drug eluting stent PCI. Although oral antiplatelet therapy is associated with both, short- as well as long-term clinical efficacy, irreversible platelet inhibition carries a substantial risk of bleeding particularly in patients presenting for surgery. Empiric therapy of bleeding consists of platelet transfusion. However, there are currently no pharmacodynamic studies assessing the effect of stored platelets on in-vitro platelet function tests.

Healthy volunteers will donate platelets, take aspirin and clopidogrel for 3 days (loading dose aspirin 300 mg, clopidogrel 300 mg, maintenance dose aspirin 100 mg, clopidogrel 75 mg) and platelets will be retransfused on the 4th day. Pharmacodynamic measurements of platelet function will be performed at baseline, after drug intake before retransfusion, immediately after retransfusion and 24 hours thereafter.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bleeding
Intervention  ICMJE
  • Other: autologous stored platelets
    Administration of autologous stored platelets
  • Other: administration of autologous stored platelets
    administration of autologous stored platelets
  • Biological: autologous stored platelets
    transfusion of autologous stored platelets
Study Arms  ICMJE Experimental: autologous stored platelets
Interventions:
  • Other: autologous stored platelets
  • Other: administration of autologous stored platelets
  • Biological: autologous stored platelets
Publications * Prüller F, Drexler C, Archan S, Macher S, Raggam RB, Mahla E. Low platelet reactivity is recovered by transfusion of stored platelets: a healthy volunteer in vivo study. J Thromb Haemost. 2011 Aug;9(8):1670-3. doi: 10.1111/j.1538-7836.2011.04392.x.

*   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: April 27, 2011)
6
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2010)
12
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Informed consent
  2. Healthy volunteers, male or female (after exclusion of pregnancy if they are on birth control pill or have a contraceptive coil implanted)
  3. Age of consent
  4. Weight: 70 kg - 100 kg
  5. Platelet count 240 000 to 440 000/µL
  6. Hematocrit > 40%
  7. readiness to refrain from any activities prone to injury during the study period.

Exclusion criteria:

  1. Allergy against aspirin or clopidogrel
  2. History of bleeding
  3. History of peptic ulcer
  4. Intake of aspirin or NSAR during the last ten days before screening
  5. Gastrointestinal disease precluding resorption of aspirin and clopidogrel
  6. Scheduled surgery
  7. Any current medication
  8. History of hepatic disease
  9. 20µm ADP induced aggregation < 60% at screening
  10. CYP2C19 polymorphisms
  11. Donation of blood within the preceding 4 weeks
  12. Neurotic disease
  13. Current smoking
  14. Drug addiction
  15. Intake of grapefruits during the last 10 days before
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01248351
Other Study ID Numbers  ICMJE PAC_2009
2009-018108-17 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Univ. Prof. Dr. Elisabeth Mahla, Medical University of Graz
Study Sponsor  ICMJE Medical University of Graz
Collaborators  ICMJE
  • Novo Nordisk A/S
  • CSL Behring
Investigators  ICMJE
Principal Investigator: Mahla Elisabeth, MD Dept. of Anesthesia and Intensive Care Medicine, Medical University of Graz
PRS Account Medical University of Graz
Verification Date April 2011

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