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

Phase 1

Completed

• Conditions: Inhibition on Platelet Aggregation
• Interventions: Drug: Ticagrelor; Drug: Clopidogrel; Drug: ASA

• Registration Number: NCT01744288
• Lead Sponsor: AstraZeneca

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-06
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-23
• Last Update Posted: 2014-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Ticagrelor	Ticagrelor without Platelet transfusion
1	Ticagrelor	Ticagrelor with Platelet transfusion
1	ASA	Ticagrelor with Platelet transfusion
2	ASA	Ticagrelor without Platelet transfusion
3	Clopidogrel	Clopidogrel with Platelet transfusion
3	ASA	Clopidogrel with Platelet transfusion
4	Clopidogrel	Clopidogrel without Platelet transfusion
4	ASA	Clopidogrel without Platelet transfusion

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables	up to 9 weeks
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 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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States