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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Inhibition on Platelet Aggregation

Treatments: Drug: ASA; Drug: Ticagrelor; Drug: Clopidogrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01744288

D5130C00079

Details and patient eligibility

About

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

Full 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

Enrollment: 258 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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258 participants in 4 patient groups

1

Experimental group

Description:

Ticagrelor with Platelet transfusion

Treatment:

Drug: Ticagrelor

Drug: ASA

2

Experimental group

Description:

Ticagrelor without Platelet transfusion

Treatment:

Drug: Ticagrelor

Drug: ASA

3

Active Comparator group

Description:

Clopidogrel with Platelet transfusion

Treatment:

Drug: ASA

Drug: Clopidogrel

4

Active Comparator group

Description:

Clopidogrel without Platelet transfusion

Treatment:

Drug: ASA

Drug: Clopidogrel