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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01744288
First received: December 5, 2012
Last updated: April 23, 2014
Last verified: April 2014
  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: Crossover 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:


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 ]

Enrollment: 258
Study Start Date: December 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Glenn Carlson, MD AstraZeneca Wilmington US
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: April 23, 2014
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
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014