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

NCT01744288 | Completed Phase 1

• 1 other identifier: D5130C00079
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inhibition on Platelet Aggregation

Keywords

Phase 1 Safety ,; pharmacodynamic,; Ticagrelor,; Clopidogrel,; Platelets

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (4)

1

EXPERIMENTAL

Ticagrelor with Platelet transfusion

Drug: Ticagrelor; Drug: ASA

2

EXPERIMENTAL

Ticagrelor without Platelet transfusion

Drug: Ticagrelor; Drug: ASA

3

ACTIVE COMPARATOR

Clopidogrel with Platelet transfusion

Drug: Clopidogrel; Drug: ASA

4

ACTIVE COMPARATOR

Clopidogrel without Platelet transfusion

Drug: Clopidogrel; Drug: ASA

Interventions

Ticagrelor DRUG

Oral single loading dose 180ng

1; 2

Clopidogrel DRUG

Oral single loading dose 600mg

3; 4

ASA DRUG

81mg once daily from day -2 up to platelet transfusion

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

Ticagrelor; Clopidogrel

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Glenn Carlson, MD

  AstraZeneca Wilmington US

  STUDY CHAIR

• Phil Leese, MD

  Overland Park US, Quintiles, Inc

  PRINCIPAL INVESTIGATOR

• Judi Hsia, MD

  Wilmington, US AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 6, 2012
• Study Start: December 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 24, 2014

Record last verified: 2014-04

Locations

US (1)