Inhibition on Platelet AggregationPhase 1NCT01744288
Study to See if Platelet Transfusion Stop or Lessen the Effect of the Drug on Platelets
A Phase 1 study testing Ticagrelor, Clopidogrel and ASA in people with Inhibition on Platelet Aggregation, run by AstraZeneca at 1 site in United States.
Trial summary
Study to see if platelet transfusion stop or lessen the effect of the drug on platelets Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Inhibition on Platelet Aggregation
- What is being tested?
- Ticagrelor, Clopidogrel and ASA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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 to see if platelet transfusion stop or lessen the effect of the drug on platelets
Read the 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
- Conditions
- Inhibition on Platelet Aggregation
- Being tested
- Ticagrelor, Clopidogrel, ASA
- Keywords
- Phase 1 Safety ,, pharmacodynamic,, Ticagrelor,, Clopidogrel,, Platelets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Oral single loading dose 180ng
ClopidogrelDrug
Oral single loading dose 600mg
ASADrug
81mg once daily from day -2 up to platelet transfusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ticagrelor with Platelet transfusion Receives: Drug: Ticagrelor; Drug: ASA |
| 2 | Experimental | Ticagrelor without Platelet transfusion Receives: Drug: Ticagrelor; Drug: ASA |
| 3 | Active comparator | Clopidogrel with Platelet transfusion Receives: Drug: Clopidogrel; Drug: ASA |
| 4 | Active comparator | Clopidogrel without Platelet transfusion Receives: Drug: Clopidogrel; Drug: ASA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inhibition on Platelet AggregationStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glenn Carlson, MD, Study chair, AstraZeneca Wilmington USPhil Leese, MD, Principal investigator, Overland Park US, Quintiles, IncJudi Hsia, MD, Study director, Wilmington, US AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744288
- Sponsor's protocol ID
- D5130C00079
- Status last verified
- Apr 2014
- First submitted
- 5 Dec 2012
- Last updated
- 24 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01744288
- Acronym / sponsor ID
- D5130C00079
- Conditions
- Inhibition on Platelet Aggregation
- Keywords
- Phase 1 Safety ,, pharmacodynamic,, Ticagrelor,, Clopidogrel,, Platelets
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ticagrelor, Drug: ASATicagrelor with Platelet transfusion |
| 2 | Experimental | Drug: Ticagrelor, Drug: ASATicagrelor without Platelet transfusion |
| 3 | Active comparator | Drug: Clopidogrel, Drug: ASAClopidogrel with Platelet transfusion |
| 4 | Active comparator | Drug: Clopidogrel, Drug: ASAClopidogrel without Platelet transfusion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorOral single loading dose 180ng | Drug | 1, 2 |
| ClopidogrelOral single loading dose 600mg | Drug | 3, 4 |
| ASA81mg once daily from day -2 up to platelet transfusion | Drug | 1, 2, 3, 4 |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn Carlson, MD study chair
AstraZeneca Wilmington US
Phil Leese, MD principal investigator
Overland Park US, Quintiles, Inc
Judi Hsia, MD study director
Wilmington, US AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ticagrelor, Clopidogrel and ASA in people with Inhibition on Platelet Aggregation, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.