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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-04-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Inhibition on Platelet Aggregation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Ticagrelor with Platelet transfusion

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

Oral single loading dose 180ng

ASA

Intervention Type DRUG

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

2

Ticagrelor without Platelet transfusion

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

Oral single loading dose 180ng

ASA

Intervention Type DRUG

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

3

Clopidogrel with Platelet transfusion

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Oral single loading dose 600mg

ASA

Intervention Type DRUG

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

4

Clopidogrel without Platelet transfusion

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Oral single loading dose 600mg

ASA

Intervention Type DRUG

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

Interventions

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Ticagrelor

Oral single loading dose 180ng

Intervention Type DRUG

Clopidogrel

Oral single loading dose 600mg

Intervention Type DRUG

ASA

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes