Acute Coronary SyndromePhase 4NCT02487732
Comparison of Ticagrelor vs. Prasugrel on Inflammation, Arterial Stiffness, Endothelial Function, and Circulating Endothelial Progenitor Cells in Diabetic Patients With Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Requiring Coronary Stenting
A Phase 4 study testing Ticagrelor and Prasugrel in people with Acute Coronary Syndrome, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
To investigate pleiotropic effects of ticagrelor in addition to its antiplatelet effects in type 2 diabetic patients with non-ST elevation acute coronary syndrome by measuring inflammatory markers, circulating number of endothelial progenitor cells, brachial artery endothelial function, and arterial stiffness. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Ticagrelor and Prasugrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to Jan 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 30 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
- Newly diagnosed type 2 diabetic patients or type 2 diabetic patients on hypoglycemic agents between the age of 30 to 70
- Non-ST elevation Acute coronary syndrome with successful coronary stent implantation (with TIMI flow grade 3 after the procedure)
Who cannot join
- Hypersensitivity to ticagrelor, prasugrel or any of the excipients
- No prior use of either ticagrelor or prasugrel within a month prior to randomization.
- History of intracranial bleeding at any time
- Active pathologic bleeding
- Hemoglobin A1c >9%
- Type 1 diabetes
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- Decreased serum platelet level (< 100,000/uL)
- Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
- Gastrointestinal bleed within the past 6 months, or major surgery within 30 days
- Renal failure requiring dialysis or anticipated need for dialysis during the course of the study
- Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study
- Involvement in the planning and/or conduct of the study
- Left ventricular ejection fraction < 40%
- Hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase > twice the upper limit)
- Gastrointestinal disorder such as Crohn's disease
- Alcohol abuse
- Steroid or hormone replacement therapy
- Serum creatinine > 2.0 mg/dL.
- Prior history of CVA or stroke
- Body weight < 60 kg
- Life expectancy less than a year
- Known pregnancy, breast-feeding, or intend to become pregnant during the study period
Trial locations and contacts
1 site in 1 country.
About this study
To investigate pleiotropic effects of ticagrelor in addition to its antiplatelet effects in type 2 diabetic patients with non-ST elevation acute coronary syndrome by measuring inflammatory markers, circulating number of endothelial progenitor cells, brachial artery endothelial function, and arterial stiffness.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Ticagrelor, Prasugrel
- Keywords
- Diabetic Patients With Non-ST Elevation
- Medical subject headings
- Acute Coronary Syndrome
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 for 5 weeks
PrasugrelDrug
Also called Effient
Prasugrel 10mg once daily for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Active comparator | 180mg loading dose, 90mg twice daily for 5 weeks, then crossover to prasugrel Receives: Drug: Ticagrelor |
| Prasugrel | Active comparator | 60mg loading dose, 10mg once daily for 5 weeks, then crossover to ticagrelor Receives: Drug: Prasugrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in circulating number of endothelial progenitor cells
Measured: Expected average of 5 weeks
Changes in brachial artery flow mediated dilation
Measured: Expected average of 5 weeks
Secondary outcomes (1)
Composite measure of brachial-ankle pulse wave velocity, and augmentation index.
Measured: Expected average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Soon Jun Hong, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487732
- Sponsor's protocol ID
- Adenosine diphosphate blockers
- Status last verified
- Apr 2019
- First submitted
- 27 Jun 2015
- Last updated
- 25 Apr 2019
- Results posted
- No
Publications
Jeong HS, Hong SJ, Cho SA, Kim JH, Cho JY, Lee SH, Joo HJ, Park JH, Yu CW, Lim DS. Comparison of Ticagrelor Versus Prasugrel for Inflammation, Vascular Function, and Circulating Endothelial Progenitor Cells in Diabetic Patients With Non-ST-Segment Elevation Acute Coronary Syndrome Requiring Coronary Stenting: A Prospective, Randomized, Crossover Trial. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1646-1658. doi: 10.1016/j.jcin.2017.05.064.
PubMed 28838475
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ticagrelor vs. Prasugrel on Inflammation, Arterial Stiffness, Endothelial Function, and Circulating Endothelial Progenitor Cells in Diabetic Patients With Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Requiring Coronary Stenting
- ClinicalTrials.gov ID
- NCT02487732
- Acronym / sponsor ID
- Adenosine diphosphate blockers
- Conditions
- Acute Coronary Syndrome
- Keywords
- Diabetic Patients With Non-ST Elevation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jul 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 1 Jul 2015 (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.
To investigate pleiotropic effects of ticagrelor in addition to its antiplatelet effects in type 2 diabetic patients with non-ST elevation acute coronary syndrome by measuring inflammatory markers, circulating number of endothelial progenitor cells, brachial artery endothelial function, and arterial stiffness.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Active comparator | Drug: Ticagrelor180mg loading dose, 90mg twice daily for 5 weeks, then crossover to prasugrel |
| Prasugrel | Active comparator | Drug: Prasugrel60mg loading dose, 10mg once daily for 5 weeks, then crossover to ticagrelor |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of informed consent prior to any study specific procedures
- Newly diagnosed type 2 diabetic patients or type 2 diabetic patients on hypoglycemic agents between the age of 30 to 70
- Non-ST elevation Acute coronary syndrome with successful coronary stent implantation (with TIMI flow grade 3 after the procedure)
Key exclusion criteria (22 listed)
- Hypersensitivity to ticagrelor, prasugrel or any of the excipients
- No prior use of either ticagrelor or prasugrel within a month prior to randomization.
- History of intracranial bleeding at any time
- Active pathologic bleeding
- Hemoglobin A1c >9%
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 for 5 weeks | Drug | Ticagrelor |
| PrasugrelAlso: EffientPrasugrel 10mg once daily for 5 weeks | Drug | Prasugrel |
Primary outcome
Changes in circulating number of endothelial progenitor cells
Time frame: Expected average of 5 weeks
Changes in brachial artery flow mediated dilation
Time frame: Expected average of 5 weeks
1 secondary outcome
Composite measure of brachial-ankle pulse wave velocity, and augmentation index.
Time frame: Expected average of 5 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 25 Apr 2019.
- Derived from this study: PubMed 28838475Jeong HS, Hong SJ, Cho SA, Kim JH, Cho JY, Lee SH, Joo HJ, Park JH, Yu CW, Lim DS. Comparison of Ticagrelor Versus Prasugrel for Inflammation, Vascular Function, and Circulating Endothelial Progenitor Cells in Diabetic Patients With Non-ST-Segment Elevation Acute Coronary Syndrome Requiring Coronary Stenting: A Prospective, Randomized, Crossover Trial. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1646-1658. doi: 10.1016/j.jcin.2017.05.064.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor and Prasugrel in people with Acute Coronary Syndrome, run by Korea University Anam Hospital at 1 site in South Korea.
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 22 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 25 Apr 2019. 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 South Korea. 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 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 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?
Changes in circulating number of endothelial progenitor cells (time frame: Expected average of 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02487732, which also lists 1 linked publication.
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 25 Apr 2019.