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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01744288

Collaborator

(none)

258

Enrollment

Location

Arms

Duration (Months)

16.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Inhibition on Platelet Aggregation	Drug: Ticagrelor Drug: Clopidogrel Drug: ASA	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

258 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official 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

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Ticagrelor with Platelet transfusion	Drug: Ticagrelor Oral single loading dose 180ng Drug: ASA 81mg once daily from day -2 up to platelet transfusion
Experimental: 2 Ticagrelor without Platelet transfusion	Drug: Ticagrelor Oral single loading dose 180ng Drug: ASA 81mg once daily from day -2 up to platelet transfusion
Active Comparator: 3 Clopidogrel with Platelet transfusion	Drug: Clopidogrel Oral single loading dose 600mg Drug: ASA 81mg once daily from day -2 up to platelet transfusion
Active Comparator: 4 Clopidogrel without Platelet transfusion	Drug: Clopidogrel Oral single loading dose 600mg Drug: ASA 81mg once daily from day -2 up to platelet transfusion

Outcome Measures

Primary Outcome Measures

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 [Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h]

Secondary Outcome Measures

Pharmacodynamics in terms of platelet reactivity as measured by P2Y12 Reaction Units (PRU) using VerifyNow™ after loading dose of Ticagrelor [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 [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 [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 [up to 9 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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