Endothelial DysfunctionPhase 4NCT02379676
Effect of Ticagrelor Versus Clopidogrel on Endothelial Dysfunction and Vascular Inflammation
A Phase 4 study testing Ticagrelor and Clopidogrel in people with Endothelial Dysfunction and Vascular Inflammation, run by Kiyuk Chang at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the effects of ticagrelor and clopidogrel on endothelial dysfunction and vascular inflammation Ticagrelor will lead to beneficial pleiotropic effects compared with treatment with clopidogrel in patients receiving a drug-eluting stents (DES) during percutaneous coronary… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Endothelial Dysfunction, Vascular Inflammation
- What is being tested?
- Ticagrelor and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Mar 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Men and women ≥20 years of age
- Documented history of non-ST-segment acute coronary syndrome occurring 30 ~ 365 days prior to randomization and successfully treated with percutaneous coronary intervention using drug-eluting stent
- Patient currently prescribed and tolerating aspirin 100mg and clopidogrel 75mg.
- Patient who have demonstrated endothelial dysfunction defined as percent flow-mediated dilation values lower than 7% at baselines test
Who cannot join
- Patients with angina related symptoms
- Patients who did not undergo or failed invasive treatment
- Patients with a history of hypersensitivity to ticagrelor or clopidogrel
- Patients who took an anti-coagulant, anti-thrombotic regularly before the study, or plan to have continuous treatment during the study
- Patients who took vasoactive agents or caffeine ingestion for <48
- Patients with decompensated congestive heart failure of cardiogenic shock (Killip classification III or IV)
Show all 21Show fewer
- Patients with intractable arrhythmia
- Patients with intractable arrhythmia
- Patients with second or third degree atrioventricular block
- Patients with uncontrolled hypertension
- Patients with high risk of hemorrhage like blood coagulation disorders, gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, intracranial hemorrhage
- Patients with more than moderate chronic obstructive pulmonary disease diagnosed by symptoms or documented by pulmonary function test
- Patients who required renal replacement therapy
- Patients with moderate to severe hepatic impairment
- Patients with platelet <100,000/μL
- Patients with hematocrit <30%
- Concomitant oral or parenteral therapy with strong cytochrome P450 3A4 inhibitors, cytochrome P450 3A substrates with narrow therapeutic indices, or strong cytochrome P450 3A4 inducers i) Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, over 1 litre daily of grapefruit juice ii) Substrates with narrow therapeutic index: cyclosporine, quinidine, simvastatin at doses >40 mg daily or lovastatin at doses >40 mg daily iii) Strong inducers: rifampin/rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital
- Patient who need to take drugs other than study medications and allowed concomitant medications during study period.
- Patients who have planned elective surgery or invasive procedure requiring temporary discontinued study medication during study period.
- Patients who are pregnant, breast feeding and not using medically acceptable birth control.
- Patients considered as unsuitable based on medical judgment by investigators.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul
Kiyuk Chang, MD, PhD, 82-2-2258-1139, kiyuk@catholic.ac.kr
Sungmin Lim, MD, 82-2-2258-1139, sungmin@catholic.ac.kr
About this study
Official title: Comparison of the Effects of Ticagrelor Versus Clopidogrel on Endothelial Dysfunction and Vascular Inflammation in Patients With Prior Non-ST-segment Acute Coronary Syndrome
The purpose of this study is to compare the effects of ticagrelor and clopidogrel on endothelial dysfunction and vascular inflammation
Ticagrelor will lead to beneficial pleiotropic effects compared with treatment with clopidogrel in patients receiving a drug-eluting stents (DES) during percutaneous coronary intervention (PCI) for non-ST-segment acute coronary syndrome (NSTE-ACS) beyond 1 month after the index event. Ticagrelor treatment will improve percent flow-mediated dilation (FMD) values and reduces inflammatory gene expression on peripheral blood mononuclear cells.
Read the detailed description
The primary objective of this study lies in whether ticagrelor improves endothelial dysfunction compared to clopidogrel, measured by endothelium-dependent flow-mediated dilation (FMD). The secondary objective is to demonstrate whether ticagrelor has an anti-atherosclerotic effect compared to clopidogrel in terms of reducing systemic low-grade inflammation. Endpoints are 1) difference of flow-mediated dilation values, and 2) messenger ribonucleic acid (mRNA) expression measured by quantitative real-time reverse transcription-polymerase chain reaction (qRT-PCR) of inflammation-associated key genes in circulation monocytes between non-ST-segment acute coronary syndrome patients treated with ticagrelor and clopidogrel.
Patients who agree to participate study are screened at Visit 1 (30 ~ 365 days after index percutaneous coronary intervention). Patients with endothelial dysfunction defined as screening flow-mediated dilation are randomly assigned at Visit 2 (0~7 days after screening test). And then, patients should receive study drugs according to allocated groups from the day of randomization. Ticagrelor 90mg twice daily or clopidogrel 75mg daily will be maintained for 30 days. Flow-mediated dilation are performed at screening and at Visit 3 (day 30 from the treatment of study drugs) and blood sampling are performed before the first dose of study drugs at Visit 2 and at Visit 3.
- Conditions
- Endothelial Dysfunction, Vascular Inflammation
- Being tested
- Ticagrelor, Clopidogrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Ticagrelor 90mg twice daily for 30 days
ClopidogrelDrug
Clopidogrel 75mg once daily for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | Ticagrelor 90mg twice daily Receives: Drug: Ticagrelor |
| Clopidogrel | Active comparator | Clopidogrel 75mg once daily Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent flow-mediated dilation (FMD) values
Measured: Baseline, 30 days
Secondary outcomes (3)
Percent flow-mediated dilation (FMD) values
Measured: Baseline, 30 days
Incidence rate of patient with percent flow-mediated dilation (FMD) value less than 7%
Measured: Baseline, 30 days
Inflammatory gene expression levels by quantitative real-time reverse transcription-polymerase chain reaction (qRT-PCR)
Measured: Baseline, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kiyuk Chang
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Kiyuk Chang, Seoul St. Mary's Hospital
- Investigators
- Kiyuk Chang, MD, PhD, Principal investigator, Seoul St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379676
- Sponsor's protocol ID
- XC14MIMI0092k
- Status last verified
- Jul 2016
- First submitted
- 28 Feb 2015
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Ticagrelor Versus Clopidogrel on Endothelial Dysfunction and Vascular Inflammation in Patients With Prior Non-ST-segment Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02379676
- Acronym / sponsor ID
- XC14MIMI0092k
- Conditions
- Endothelial Dysfunction, Vascular Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Kiyuk ChangUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 5 Mar 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.
The purpose of this study is to compare the effects of ticagrelor and clopidogrel on endothelial dysfunction and vascular inflammation
Ticagrelor will lead to beneficial pleiotropic effects compared with treatment with clopidogrel in patients receiving a drug-eluting stents (DES) during percutaneous coronary intervention (PCI) for non-ST-segment acute coronary syndrome (NSTE-ACS) beyond 1 month after the index event. Ticagrelor treatment will improve percent flow-mediated dilation (FMD) values and reduces inflammatory gene expression on peripheral blood mononuclear cells.
Detailed description
The primary objective of this study lies in whether ticagrelor improves endothelial dysfunction compared to clopidogrel, measured by endothelium-dependent flow-mediated dilation (FMD). The secondary objective is to demonstrate whether ticagrelor has an anti-atherosclerotic effect compared to clopidogrel in terms of reducing systemic low-grade inflammation. Endpoints are 1) difference of flow-mediated dilation values, and 2) messenger ribonucleic acid (mRNA) expression measured by quantitative real-time reverse transcription-polymerase chain reaction (qRT-PCR) of inflammation-associated key genes in circulation monocytes between non-ST-segment acute coronary syndrome patients treated with ticagrelor and clopidogrel.
Patients who agree to participate study are screened at Visit 1 (30 ~ 365 days after index percutaneous coronary intervention). Patients with endothelial dysfunction defined as screening flow-mediated dilation are randomly assigned at Visit 2 (0~7 days after screening test). And then, patients should receive study drugs according to allocated groups from the day of randomization. Ticagrelor 90mg twice daily or clopidogrel 75mg daily will be maintained for 30 days. Flow-mediated dilation are performed at screening and at Visit 3 (day 30 from the treatment of study drugs) and blood sampling are performed before the first dose of study drugs at Visit 2 and at Visit 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: TicagrelorTicagrelor 90mg twice daily |
| Clopidogrel | Active comparator | Drug: ClopidogrelClopidogrel 75mg once daily |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of informed consent prior to any study specific procedures
- Men and women ≥20 years of age
- Documented history of non-ST-segment acute coronary syndrome occurring 30 ~ 365 days prior to randomization and successfully treated with percutaneous coronary intervention using drug-eluting stent
- Patient currently prescribed and tolerating aspirin 100mg and clopidogrel 75mg.
- Patient who have demonstrated endothelial dysfunction defined as percent flow-mediated dilation values lower than 7% at baselines test
Key exclusion criteria (21 listed)
- Patients with angina related symptoms
- Patients who did not undergo or failed invasive treatment
- Patients with a history of hypersensitivity to ticagrelor or clopidogrel
- Patients who took an anti-coagulant, anti-thrombotic regularly before the study, or plan to have continuous treatment during the study
- Patients who took vasoactive agents or caffeine ingestion for <48
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 |
|---|---|---|
| TicagrelorTicagrelor 90mg twice daily for 30 days | Drug | Ticagrelor |
| ClopidogrelClopidogrel 75mg once daily for 30 days | Drug | Clopidogrel |
Primary outcome
Change in percent flow-mediated dilation (FMD) values
Time frame: Baseline, 30 days
3 secondary outcomes
Percent flow-mediated dilation (FMD) values
Time frame: Baseline, 30 days
Incidence rate of patient with percent flow-mediated dilation (FMD) value less than 7%
Time frame: Baseline, 30 days
Inflammatory gene expression levels by quantitative real-time reverse transcription-polymerase chain reaction (qRT-PCR)
Time frame: Baseline, 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
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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.
Kiyuk Chang, MD, PhD principal investigator
Seoul St. Mary's Hospital, The Catholic University of Korea
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 Clopidogrel in people with Endothelial Dysfunction and Vascular Inflammation, run by Kiyuk Chang 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 5 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 6 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kiyuk Chang, MD, PhD (82-2-2258-1139, kiyuk@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percent flow-mediated dilation (FMD) values (time frame: Baseline, 30 days). 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 6 Jul 2016.