Thrombosis; ArteryNCT04088123
Impact of Anti-platelet Drug Exposure on Platelet mRNA Splicing in Healthy Subjects
An observational study of Thrombosis; Artery, run by George Washington University at 2 sites in United States.
Trial summary
The purpose of this pilot study is to determine how the anti-platelet drug, ticagrelor, impacts platelet mRNA splicing after a single loading dose in 10 healthy participants. These results will be valuable in that they will help inform our analysis of platelet RNA splicing after a thrombotic event. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thrombosis; Artery
- What is being tested?
- Ticagrelor Oral Tablet [Brilinta]
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2020to 23 Sep 2020
- Phase
- Observational
- 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 70 years
- All sexes
- Adult, Older adult
Study population: Healthy patients who meet our inclusion and exclusion criteria
Who may be able to join
- 18 - 70 years-old
- Speak and understand English
Who cannot join
- History of blood clotting/bleeding disorders
- Current medications that are CYP3A4 inhibitors/inducers
- Current medications that their pharmacokinetics is impacted by ticagrelor (i.e. simvastatin, lovastatin, digoxin) per FDA recommendations.
- Diagnosed with arterial or venous thrombosis
- Active cancer diagnosis
- Pregnant
Show all 9Show fewer
- Hepatic impairment including active hepatitis infection or cirrhosis
- Current hormonal contraception
- Currently taking aspirin or anti-platelet drugs. If patient has recently taken an NSAID, the last dose should have been discontinued based established criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Shenandoah University Bernard J. Dunn School of Pharmacy
Fairfax, Virginia, 22601
The George Washington University School of Medicine and Health Sciences
Washington D.C., District of Columbia, 20037
About this study
Official title: Investigation of Anti-platelet Drug Single Dose Exposure on Platelet mRNA Splicing in Healthy Subjects
The purpose of this pilot study is to determine how the anti-platelet drug, ticagrelor, impacts platelet mRNA splicing after a single loading dose in 10 healthy participants. These results will be valuable in that they will help inform our analysis of platelet RNA splicing after a thrombotic event.
Read the detailed description
There is nothing known on how differential splicing in platelets is impacted by of P2Y12 inhibition by anti-platelet agents. Consequently, the focus of this longitudinal pilot study will be to determine the impact of a single ticagrelor loading dose (180 mg), our "model" anti-platelet drug, on platelet RNA splicing in 10 healthy individuals.
It will test the hypothesis that ticagrelor exposure does not significantly alter platelet mRNA splicing. It will involve administering a single loading dose (180 mg) of ticagrelor to healthy volunteers.
- Conditions
- Thrombosis; Artery
- Being tested
- Ticagrelor Oral Tablet [Brilinta]
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor Oral Tablet [Brilinta]Drug
Also called Brilinta
A single loading dose of ticagrelor (180 mg) will be administered to each participant in this study.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Patients | The study design will involve analysis of platelet splicing/activity before and after exposure to a single, 180 mg loading dose of ticagrelor. All subjects will be cardiovascular healthy. Receives: Drug: Ticagrelor Oral Tablet [Brilinta] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the Change in Platelet Activity From Baseline after Drug Administration
As determined by the VerifyNow P2Y12 Assay
Measured: Comparison made 2.5 hours following drug administration
Measurement of the Change in Platelet mRNA splicing From Baseline after Drug Administration
As determined by RNAseq analysis
Measured: Comparison made 2.5 hours following drug administration
Measurement of Ticagrelor Pharmacokinetics After Drug Administration
Drug and its major metabolite levels will be measured by HPLC
Measured: Comparison made 2.5 hours following drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start1 Apr 2020 (estimated)
- Primary completion23 Sep 2020
- Study completion23 Sep 2020
Why it stopped: Inability to commence enrollment at institution, terminated on 9/23/20
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombosis; ArteryStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Shenandoah University, The GW Medical Faculty Associates
- Responsible party
- Principal investigator, Travis J. O'Brien, George Washington University
- Investigators
- Travis J O'Brien, PHD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088123
- Sponsor's protocol ID
- NCR191544
- Other IDs
- U54MD010723, Pharmacy Faculty Fund, PIND 144269
- Status last verified
- Oct 2021
- First submitted
- 10 Sep 2019
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with researchers. Only aggregate data from the study
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Anti-platelet Drug Single Dose Exposure on Platelet mRNA Splicing in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04088123
- Acronym / sponsor ID
- NCR191544
- Conditions
- Thrombosis; Artery
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Inability to commence enrollment at institution, terminated on 9/23/20
- Enrolment
- 0 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Shenandoah University, The GW Medical Faculty Associates
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 12 Sep 2019 (actual)
- 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.
The purpose of this pilot study is to determine how the anti-platelet drug, ticagrelor, impacts platelet mRNA splicing after a single loading dose in 10 healthy participants. These results will be valuable in that they will help inform our analysis of platelet RNA splicing after a thrombotic event.
Detailed description
There is nothing known on how differential splicing in platelets is impacted by of P2Y12 inhibition by anti-platelet agents. Consequently, the focus of this longitudinal pilot study will be to determine the impact of a single ticagrelor loading dose (180 mg), our "model" anti-platelet drug, on platelet RNA splicing in 10 healthy individuals.
It will test the hypothesis that ticagrelor exposure does not significantly alter platelet mRNA splicing. It will involve administering a single loading dose (180 mg) of ticagrelor to healthy volunteers.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Patients | – | Drug: Ticagrelor Oral Tablet [Brilinta]The study design will involve analysis of platelet splicing/activity before and after exposure to a single, 180 mg loading dose of ticagrelor. All subjects will be cardiovascular healthy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy patients who meet our inclusion and exclusion criteria
Key inclusion criteria (2 listed)
- 18 - 70 years-old
- Speak and understand English
Key exclusion criteria (9 listed)
- History of blood clotting/bleeding disorders
- Current medications that are CYP3A4 inhibitors/inducers
- Current medications that their pharmacokinetics is impacted by ticagrelor (i.e. simvastatin, lovastatin, digoxin) per FDA recommendations.
- Diagnosed with arterial or venous thrombosis
- Active cancer diagnosis
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 |
|---|---|---|
| Ticagrelor Oral Tablet [Brilinta]Also: BrilintaA single loading dose of ticagrelor (180 mg) will be administered to each participant in this study. | Drug | Healthy Patients |
Primary outcome
Measurement of the Change in Platelet Activity From Baseline after Drug Administration
Time frame: Comparison made 2.5 hours following drug administration
As determined by the VerifyNow P2Y12 Assay
Measurement of the Change in Platelet mRNA splicing From Baseline after Drug Administration
Time frame: Comparison made 2.5 hours following drug administration
As determined by RNAseq analysis
Measurement of Ticagrelor Pharmacokinetics After Drug Administration
Time frame: Comparison made 2.5 hours following drug administration
Drug and its major metabolite levels will be measured by HPLC
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Individual participant dataSharing planned: No. No IPD will be shared with researchers. Only aggregate data from the study
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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.
Travis J O'Brien, PHD principal investigator
George Washington University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosis; Artery, run by George Washington University at 2 sites 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 2 inclusion and 9 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: withdrawn, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Measurement of the Change in Platelet Activity From Baseline after Drug Administration (time frame: Comparison made 2.5 hours following drug administration). The study lists 3 primary outcomes in all. 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 28 Oct 2021.