Study to See if Platelet Transfusion Stop or Lessen the Effect of the Drug on Platelets - Full Text View

Purpose

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

Condition	Intervention	Phase
Inhibition on Platelet Aggregation	Drug: Ticagrelor Drug: Clopidogrel Drug: ASA	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation

Drug Information available for: Clopidogrel bisulfate Ticagrelor

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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 [ Time Frame: Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	48
Study Start Date:	December 2012
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744288

Contacts

Contact: AstraZeneca Clinical Study Information	800-236-9933	information.center@astrazeneca.com
Contact: rQuintiles Overland Park Volunteer Recruitment	913-894-5533

Locations

United States, Kansas
Research Site	Recruiting
Overland Park, Kansas, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:	Mirjana Kujacic, MD	Molndal, Sweden AstraZeneca
Principal Investigator:	Phil Leese, MD	Overland Park US, Quintiles, Inc
Study Director:	Judi Hsia, MD	Wilmington, US AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01744288 History of Changes
Other Study ID Numbers:	D5130C00079
Study First Received:	December 5, 2012
Last Updated:	January 11, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Phase 1 Safety ,
pharmacodynamic,
Ticagrelor,
Clopidogrel,
Platelets

Additional relevant MeSH terms:

Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists

Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013