Platelet Aggregation InhibitorsEarly Phase 1NCT05278637
GM03 - Platelet RNA Signatures of Aspirin
A Early Phase 1 study testing Aspirin and Ticagrelor in people with Platelet Aggregation Inhibitors and Aspirin, run by Duke University at 1 site in United States.
Trial summary
This study will involve healthy volunteers and patients with Type 2 diabetes. Eligible healthy volunteers will be invited to enroll into one of two protocols (A or B) and eligible patients with diabetes will be enrolled into protocol A. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet Aggregation Inhibitors, Aspirin, Ticagrelor
- What is being tested?
- Aspirin and Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2013to 5 Dec 2016
- Phase
- Early 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Age ≥ 30 and ≤ 75
- Non-smoker
- The total number of enrolled females should not exceed 55% of the entire cohort. Therefore, the PI may include/exclude individuals on the basis of gender to achieve an equal balance between men and women.
Who cannot join
- History of bleeding disorder, gastrointestinal bleeding, intracranial bleeding or known prior gastric ulcer without documented resolution
- Current regular use of antiplatelet agents (aspirin, cilostazol, prasugrel, clopidogrel, dipyridamole, ticagrelor, or ticlopidine), nonsteroidal anti-inflammatory agents (NSAIDs), oral corticosteroids (i.e. prednisone), anticoagulants (warfarin, dabigatran, apixaban, rivaroxaban, enoxaparin)
- Known, severe hepatic impairment
- Surgery within the last 6 months, at the discretion of the PI
- Prior gastric bypass surgery (or equivalent) that interferes with absorbption at the discretion of the PI
- Aspirin allergy or known intolerance to aspirin or ticagrelor.
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- Comorbid conditions:
- hypertension (requiring prescription medication).
- hyperlipidemia (requiring medications)
- Type 1 or 2 Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DEVELOPMENT OF PROGNOSTIC PLATELET RNA BIOMARKERS TO TAILOR ANTIPLATELET THERAPY
This study will involve healthy volunteers and patients with Type 2 diabetes. Eligible healthy volunteers will be invited to enroll into one of two protocols (A or B) and eligible patients with diabetes will be enrolled into protocol A.
Read the detailed description
Protocol A This will be a randomized, cross-over design comparing low- and high-dose aspirin as well as a non-aspirin platelet inhibitor ticagrelor. This antiplatelet exposure study will be conducted at the DCRU using two separate cohorts: 1) healthy adult volunteers 2) patients with Type 2 diabetes. Subjects within each cohort will but in general will have platelet function testing and biospecimen collection before, four weeks, and eight weeks after low- or high-dose aspirin exposure. Subsequently there will be a period of aspirin washout and a four-week exposure to ticagrelor, a non-aspirin platelet inhibitor. In all subjects and at various time points peripheral blood RNA, purified platelets, DNA, serum, fecal samples and/or plasma will be collected.
Protocol B This will be a single arm study of the platelet inhibitor ticagrelor that is essentially the last two visits of Protocol A. This study will be conducted at the DCRU and will only be open to healthy adult volunteers and patients with Type 2 diabetes. Subjects who elect to participate in this protocol will follow the protocol outlined in Figure 2 and in general will have platelet function testing and biospecimen collection before and four weeks after exposure to ticagrelor, a non-aspirin platelet inhibitor. In all subjects and at various time points (see Figure 2 and Table 2) peripheral blood RNA, purified platelets, DNA, serum, and/ plasma will be collected. In order to align the visits with that of Protocol A, the two visits under this protocol will be labelled V4 and V5.
- Conditions
- Platelet Aggregation Inhibitors, Aspirin, Ticagrelor, RNA
- Being tested
- Aspirin, Ticagrelor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Aspirin 81mg/day x 4 weeks, Aspirin 325mg/day x 4 weeks. or Aspirin 325mg/day x 4 weeks, Aspirin 81mg/day x 4 weeks.
TicagrelorDrug
Ticagrelor 90mg BID x 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aspirin 81mg/day, Aspirin 325mg/day, Aspirin washout, Ticagrelor 90mg BID | Active comparator | Not described Receives: Drug: Aspirin; Drug: Ticagrelor |
| Aspirin 325mg/day, Aspirin 81mg/day, Aspirin washout, Ticagrelor 90mg BID | Active comparator | Not described Receives: Drug: Aspirin; Drug: Ticagrelor |
| Ticagrelor 90mg BID | Active comparator | Not described Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in expression levels of platelet messenger RNA
Measured: Baseline, after every 4 week exposure
Secondary outcomes (1)
Change in platelet function score
Measured: Baseline, 3 hours, after every 4 week exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Nov 2013
- Primary completion5 Dec 2016
- Study completion5 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Aggregation InhibitorsStudies of the same condition, open and under way.
- More trials run by Duke 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 1. Aspirin 81mg/day x 4 weeks, Aspirin 325mg/day x 4 weeks, Aspirin washout, Ticagrelor 90mg BID x 4 weeks. 2. Aspirin 325mg/day x 4 weeks, Aspirin 81mg/day x 4 weeks, Aspirin washout, Ticagrelor 90mg BID x 4 weeks.
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deepak Voora, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278637
- Sponsor's protocol ID
- Pro00048621
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEVELOPMENT OF PROGNOSTIC PLATELET RNA BIOMARKERS TO TAILOR ANTIPLATELET THERAPY
- ClinicalTrials.gov ID
- NCT05278637
- Acronym / sponsor ID
- Pro00048621
- Conditions
- Platelet Aggregation Inhibitors, Aspirin, Ticagrelor, RNA
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 5 Dec 2016 (actual)
- Study completion
- 5 Dec 2016 (actual)
- First posted
- 14 Mar 2022 (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.
This study will involve healthy volunteers and patients with Type 2 diabetes. Eligible healthy volunteers will be invited to enroll into one of two protocols (A or B) and eligible patients with diabetes will be enrolled into protocol A.
Detailed description
Protocol A This will be a randomized, cross-over design comparing low- and high-dose aspirin as well as a non-aspirin platelet inhibitor ticagrelor. This antiplatelet exposure study will be conducted at the DCRU using two separate cohorts: 1) healthy adult volunteers 2) patients with Type 2 diabetes. Subjects within each cohort will but in general will have platelet function testing and biospecimen collection before, four weeks, and eight weeks after low- or high-dose aspirin exposure. Subsequently there will be a period of aspirin washout and a four-week exposure to ticagrelor, a non-aspirin platelet inhibitor. In all subjects and at various time points peripheral blood RNA, purified platelets, DNA, serum, fecal samples and/or plasma will be collected.
Protocol B This will be a single arm study of the platelet inhibitor ticagrelor that is essentially the last two visits of Protocol A. This study will be conducted at the DCRU and will only be open to healthy adult volunteers and patients with Type 2 diabetes. Subjects who elect to participate in this protocol will follow the protocol outlined in Figure 2 and in general will have platelet function testing and biospecimen collection before and four weeks after exposure to ticagrelor, a non-aspirin platelet inhibitor. In all subjects and at various time points (see Figure 2 and Table 2) peripheral blood RNA, purified platelets, DNA, serum, and/ plasma will be collected. In order to align the visits with that of Protocol A, the two visits under this protocol will be labelled V4 and V5.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1. Aspirin 81mg/day x 4 weeks, Aspirin 325mg/day x 4 weeks, Aspirin washout, Ticagrelor 90mg BID x 4 weeks. 2. Aspirin 325mg/day x 4 weeks, Aspirin 81mg/day x 4 weeks, Aspirin washout, Ticagrelor 90mg BID x 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Aspirin 81mg/day, Aspirin 325mg/day, Aspirin washout, Ticagrelor 90mg BID | Active comparator | Drug: Aspirin, Drug: Ticagrelor |
| Aspirin 325mg/day, Aspirin 81mg/day, Aspirin washout, Ticagrelor 90mg BID | Active comparator | Drug: Aspirin, Drug: Ticagrelor |
| Ticagrelor 90mg BID | Active comparator | Drug: Ticagrelor |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers
- Age ≥ 30 and ≤ 75
- Non-smoker
- The total number of enrolled females should not exceed 55% of the entire cohort. Therefore, the PI may include/exclude individuals on the basis of gender to achieve an equal balance between men and women.
Key exclusion criteria (10 listed)
- History of bleeding disorder, gastrointestinal bleeding, intracranial bleeding or known prior gastric ulcer without documented resolution
- Current regular use of antiplatelet agents (aspirin, cilostazol, prasugrel, clopidogrel, dipyridamole, ticagrelor, or ticlopidine), nonsteroidal anti-inflammatory agents (NSAIDs), oral corticosteroids (i.e. prednisone), anticoagulants (warfarin, dabigatran, apixaban, rivaroxaban, enoxaparin)
- Known, severe hepatic impairment
- Surgery within the last 6 months, at the discretion of the PI
- Prior gastric bypass surgery (or equivalent) that interferes with absorbption at the discretion of the PI
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 |
|---|---|---|
| AspirinAspirin 81mg/day x 4 weeks, Aspirin 325mg/day x 4 weeks. or Aspirin 325mg/day x 4 weeks, Aspirin 81mg/day x 4 weeks. | Drug | Aspirin 325mg/day, Aspirin 81mg/day, Aspirin washout, Ticagrelor 90mg BID, Aspirin 81mg/day, Aspirin 325mg/day, Aspirin washout, Ticagrelor 90mg BID |
| TicagrelorTicagrelor 90mg BID x 4 weeks | Drug | Aspirin 325mg/day, Aspirin 81mg/day, Aspirin washout, Ticagrelor 90mg BID, Aspirin 81mg/day, Aspirin 325mg/day, Aspirin washout, Ticagrelor 90mg BID, Ticagrelor 90mg BID |
Primary outcome
Change in expression levels of platelet messenger RNA
Time frame: Baseline, after every 4 week exposure
1 secondary outcome
Change in platelet function score
Time frame: Baseline, 3 hours, after every 4 week exposure
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 14 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Deepak Voora, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aspirin and Ticagrelor in people with Platelet Aggregation Inhibitors and Aspirin, run by Duke University 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 4 inclusion and 10 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 14 Mar 2022. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in expression levels of platelet messenger RNA (time frame: Baseline, after every 4 week exposure). 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 14 Mar 2022.