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Study to See if Platelet Transfusion Stop or Lessen the Effect of the Drug on Platelets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01744288
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : April 24, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE December 5, 2012
First Posted Date  ICMJE December 6, 2012
Last Update Posted Date April 24, 2014
Study Start Date  ICMJE December 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
Pharmacodynamics in terms of percent of inhibition of adenosine phosphatase (ADP)-induced platelet aggregation assessed by light transmission aggregometry (LTA) after loading dose of Ticagrelor [ Time Frame: Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
  • Pharmacodynamics in terms of platelet reactivity as measured by P2Y12 Reaction Units (PRU) using VerifyNow™ after loading dose of Ticagrelor [ Time Frame: Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h ]
  • Pharmacodynamics in terms of platelet reactivity as measured by P2Y12 Reaction Units (PRU) using VerifyNow™ after loading dose of Clopidogrel [ Time Frame: Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h ]
  • Pharmacodynamics in terms of percent of inhibition of adenosine phosphatase (ADP)-induced platelet aggregation assessed by light transmission aggregometry (LTA) after loading dose of Clopidogrel [ Time Frame: Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h ]
  • Safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables [ Time Frame: up to 9 weeks ]
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 Study to See if Platelet Transfusion Stop or Lessen the Effect of the Drug on Platelets
Official Title  ICMJE A Open Label, Randomized, Crossover and Potential Parallel, Single Dose Study of Ticagrelor 180 mg and Acetylsalicylic Acid (ASA) in Healthy Volunteers Followed by Autologous in Vivo Platelet Transfusion to Determine the Effects of Platelet Supplementation on the Reversibility of Platelet Inhibition
Brief Summary Study to see if platelet transfusion stop or lessen the effect of the drug on platelets
Detailed Description A open label, randomized, crossover and potential parallel, single dose study of ticagrelor 180 mg and acetylsalicylic acid (ASA) in healthy volunteers followed by autologous in vivo platelet transfusion to determine the effects of platelet supplementation on the reversibility of platelet inhibition
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Inhibition on Platelet Aggregation
Intervention  ICMJE
  • Drug: Ticagrelor
    Oral single loading dose 180ng
  • Drug: Clopidogrel
    Oral single loading dose 600mg
  • Drug: ASA
    81mg once daily from day -2 up to platelet transfusion
Study Arms  ICMJE
  • Experimental: 1
    Ticagrelor with Platelet transfusion
    Interventions:
    • Drug: Ticagrelor
    • Drug: ASA
  • Experimental: 2
    Ticagrelor without Platelet transfusion
    Interventions:
    • Drug: Ticagrelor
    • Drug: ASA
  • Active Comparator: 3
    Clopidogrel with Platelet transfusion
    Interventions:
    • Drug: Clopidogrel
    • Drug: ASA
  • Active Comparator: 4
    Clopidogrel without Platelet transfusion
    Interventions:
    • Drug: Clopidogrel
    • Drug: ASA
Publications * Not Provided

*   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 23, 2014)
258
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2012)
48
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of signed and dated, written informed consent prior to any study specific procedures
  • Healthy male and/or female volunteers aged 18 to 50 years, inclusive, with suitable veins for cannulation or repeated venipuncture. (Healthy as determined by medical history and physical examination, laboratory parameters, electrocardiogram (ECG) perform
  • Have a body mass index (BMI) between 18 and 35 kg/m2 (inclusive) and weigh at least 50 kg and no more than 120 kg

Exclusion Criteria:

  • ADP induced platelet aggregation <60% prior to platelet apheresis
  • History of peptic ulcer disease Healthy volunteers with a propensity to bleed (eg, due to recent trauma, recent surgery, active or recent gastrointestinal bleeding or moderate hepatic impairment)
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
  • Current smokers, those who have smoked or used nicotine products within the previous 3 months and those who tested positive for cotinine at screening or at admission to the study center
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT01744288
Other Study ID Numbers  ICMJE D5130C00079
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Glenn Carlson, MD AstraZeneca Wilmington US
Principal Investigator: Phil Leese, MD Overland Park US, Quintiles, Inc
Study Director: Judi Hsia, MD Wilmington, US AstraZeneca
PRS Account AstraZeneca
Verification Date April 2014

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