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OpenTrials
Completed

NCT Number: NCT01744288

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

Study to see if platelet transfusion stop or lessen the effect of the drug on platelets

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Overland Park, Kansas, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor

Drug

Oral single loading dose 180ng

clopidogrel

Drug

Oral single loading dose 600mg

ASA

Drug

81mg once daily from day -2 up to platelet transfusion

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2012
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.