Diabetes MellitusPhase 4NCT03027934
A Single Center Study to Evaluate Ticagrelor Mechanism of Action in Inhibiting Juvenile Platelet ADP Response
A Phase 4 study testing Ticagrelor and Prasugrel in people with Diabetes Mellitus, run by CirQuest Labs, LLC.
Trial summary
The overall objective of this study is to assess P2Y12 inhibition ex vivo in blood samples obtained from diabetic subjects who will be administered one of the two P2Y12 antagonists in a cross-over design. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Ticagrelor and Prasugrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2017to 31 Oct 2017
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Male or female aged 18 to 70 years, inclusive.
- Documented current medical history of diabetes controlled by either medication or diet and/or exercise.
- Women must have a negative urine pregnancy test.
Who cannot join
- Pregnant or lactating females, or females of child-bearing potential (i.e., those who are not chemically or surgically sterilized or who are not post-menopause) or those who are not willing to use a medically accepted method of contraception that is considered reliable in the judgement of the investigator throughout the duration of the study or females who have a positive pregnancy test at screening.
- Weight of less than 135 lbs.
- Currently prescribed and taking clopidogrel (generic or Plavix), ticagrelor (Brilinta) or prasugrel (Effient) or have taken within the past 10 days.
- Current medications:
- PAR-1 antagonist (vorapaxar/Zontivity) or within the last month.
- Phosphodiesterase inhibitors such as cilostazol (Pletal).
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- Glycoprotein IIb/IIIa inhibitors or within the last ten days (Integrilin, Aggrastat, ReoPro).
- Adenosine reuptake inhibitors such as dipyridamole (Aggrenox, Persantine)
- Coumadin.
- Heparin including low molecular weight heparin.
- Factor Xa inhibitors (e.g., enoxaparin, rivaroxaban, apixaban, and edoxaban).
- Direct thrombin inhibitors (e.g., hirudin, bivalirudin, dabigatran.
- Concomitant therapy with strong CYP3A inhibitors, such as atanazavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazadone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconizole,
- Concomitant therapy with potent CYP3A inducers, such as rifampin, phenytoin, carbamazepine, and phenobarbital.
- Increased bleeding risk including:
- Recent (within 30 days) GI bleeding
- Active pathological bleeding
- Any history of intracranial, intraocular, retroperitoneal, or spinal bleeding
- Prior history of transient ischemic attack or stroke
- Recent (within 3 months) major trauma
- Sustained uncontrolled hypertension (systolic blood pressure [SBP] > 180mmHg or diastolic blood pressure [DBP] > 100mmHg
- History of hemorrhagic disorders that can increase the risk of bleeding (e.g., hemophilia, von Willebrand's disease)
- Patients that have used within 30 days of screening, any oral or parenteral anti-thrombotic agent.
- Platelet count less than 100,000 mm3 or hemoglobin < 10g/dL
- Contraindication or other reason that ticagrelor or prasugrel should not be administered (e.g., known hypersensitivity to medication or any medication component)
- A history of alcohol and/or substance abuse that could interfere with conduct of the trial.
- Known active or recurrent hepatic disorder (including cirrhosis, hepatitis B and hepatitis C, or confirmed (ALT/AST) levels > 3 times ULN or total bilirubin > 2 times ULN at screening.
- Scheduled for revascularization (e.g., PCI, CABG) during the study period.
- Any Acute Coronary Syndrome (ACS) event within the past 6 months.
- Participation in another investigational drug or device study within 30 days of dosing.
- Any acute or chronic unstable condition in the past 30 days or other condition which, in the opinion of the investigator, may either put the subject at risk or influence the result of the study (e.g., active cancer, risk for non-compliance, risk for lost to follow-up).
About this study
Official title: A Single Center, Randomized, Open Label, Crossover Study With Ticagrelor and Prasugrel to Evaluate Ticagrelor Mechanism of Action in Inhibiting Juvenile Platelet ADP Response
The overall objective of this study is to assess P2Y12 inhibition ex vivo in blood samples obtained from diabetic subjects who will be administered one of the two P2Y12 antagonists in a cross-over design.
- Conditions
- Diabetes Mellitus
- Being tested
- Ticagrelor, Prasugrel
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Brilinta
Ticagrelor, 90mg twice daily
PrasugrelDrug
Also called Effient
Prasurgrel, 10mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Not described Receives: Drug: Ticagrelor; Drug: Prasugrel |
| Group 2 | Active comparator | Not described Receives: Drug: Ticagrelor; Drug: Prasugrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggregation Response
Comparison of aggregation response using ADP in subjects receiving prasurgrel versus ticagrelor
Measured: 23 hr Day 5
Secondary outcomes (1)
Reticulated Platelet Reactivity Index (PRI)
Comparison of PRI as measured by VASP in subjects receiving ticagrelor versus subjects receiving prasugrel
Measured: 23 hr Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start28 Aug 2017 (estimated)
- Primary completion31 Oct 2017 (estimated)
- Study completion31 Oct 2017 (estimated)
Why it stopped: Study population difficult to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CirQuest Labs, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayaprakash Kotha, Principal investigator, CirQuest Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027934
- Sponsor's protocol ID
- ESR-14-10619
- Status last verified
- Jul 2020
- First submitted
- 18 Jan 2017
- Last updated
- 15 Jul 2020
- 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 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Open Label, Crossover Study With Ticagrelor and Prasugrel to Evaluate Ticagrelor Mechanism of Action in Inhibiting Juvenile Platelet ADP Response
- ClinicalTrials.gov ID
- NCT03027934
- Acronym / sponsor ID
- ESR-14-10619
- Conditions
- Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study population difficult to recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CirQuest Labs, LLCUniversity, hospital or other
- Study start
- 28 Aug 2017 (estimated)
- Primary completion
- 31 Oct 2017 (estimated)
- Study completion
- 31 Oct 2017 (estimated)
- First posted
- 23 Jan 2017 (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.
The overall objective of this study is to assess P2Y12 inhibition ex vivo in blood samples obtained from diabetic subjects who will be administered one of the two P2Y12 antagonists in a cross-over design.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Ticagrelor, Drug: Prasugrel |
| Group 2 | Active comparator | Drug: Ticagrelor, Drug: Prasugrel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of informed consent prior to any study specific procedures
- Male or female aged 18 to 70 years, inclusive.
- Documented current medical history of diabetes controlled by either medication or diet and/or exercise.
- Women must have a negative urine pregnancy test.
Key exclusion criteria (31 listed)
- Pregnant or lactating females, or females of child-bearing potential (i.e., those who are not chemically or surgically sterilized or who are not post-menopause) or those who are not willing to use a medically accepted method of contraception that is considered reliable in the judgement of the investigator throughout the duration of the study or females who have a positive pregnancy test at screening.
- Weight of less than 135 lbs.
- Currently prescribed and taking clopidogrel (generic or Plavix), ticagrelor (Brilinta) or prasugrel (Effient) or have taken within the past 10 days.
- Current medications:
- Increased bleeding risk including:
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 |
|---|---|---|
| TicagrelorAlso: BrilintaTicagrelor, 90mg twice daily | Drug | Group 1, Group 2 |
| PrasugrelAlso: EffientPrasurgrel, 10mg once daily | Drug | Group 1, Group 2 |
Primary outcome
Aggregation Response
Time frame: 23 hr Day 5
Comparison of aggregation response using ADP in subjects receiving prasurgrel versus ticagrelor
1 secondary outcome
Reticulated Platelet Reactivity Index (PRI)
Time frame: 23 hr Day 5
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 15 Jul 2020.
- 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.
Jayaprakash Kotha principal investigator
CirQuest Labs
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor and Prasugrel in people with Diabetes Mellitus, run by CirQuest Labs, LLC.
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 31 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 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Aggregation Response (time frame: 23 hr Day 5). 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 15 Jul 2020.