Coronary Artery DiseasePhase 4NCT01957540
Differential Effect of Ticagrelor Versus Prasugrel Maintenance Dose on Endothelial Function of Peripheral Vessels in Patients With Coronary Artery Disease
A Phase 4 study testing Ticagrelor and Prasugrel in people with Coronary Artery Disease and Endothelial Function, run by University of Patras at 1 site in Greece.
Trial summary
Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in overall mortality and thrombotic cardiovascular (CV) events when directly compared to clopidogrel in the PLATO trial, implicating possible pleiotropic actions for the drug. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Coronary Artery Disease, Endothelial Function
- What is being tested?
- Ticagrelor and Prasugrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2014to Dec 2015
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-74 years old
- Patients with stable CAD who have been submitted(?) to percutaneous intervention for Acute Coronary Syndrome and receiving prasugrel MD 10mg once a day for at least the previous 3 months.
- Patients giving written Informed Consent.
Who cannot join
- Acute Coronary Syndrome
- Contraindication for administration of prasugrel or ticagrelor
- Known hypersensitivity to clopidogrel or ticagrelor
- Active bleeding (peptic ulcer, intracranial bleeding)
- Severe liver impairment
- Any previous history of intracranial bleeding or transient ischemic attack or ischemic cerebrovascular event
Show all 13Show fewer
- Treatment with potent CYP3A4 inhibitors (ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir)
- Requirement for oral anticoagulant agents prior to the day 30 visit
- History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months
- Increased risk for bradyarrhythmias, according to the investigator's evaluation
- Severe non-controlled chronic obstructive pulmonary disease
- Creatinine clearance <30ml/min/1.73mm2
- HbA1c > 10mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in overall mortality and thrombotic cardiovascular (CV) events when directly compared to clopidogrel in the PLATO trial, implicating possible pleiotropic actions for the drug. It has been shown that ticagrelor increases adenosine concentration, by interfering with its red blood cells' uptake and by inducing the release of ATP which is then converted to adenosine. Recent studies in healthy volunteers and patients with coronary artery disease (CAD) have shown that ticagrelor increases the coronary blood flow in response to intravenous adenosine administration. Ticagrelor administration, in comparison with other P2Y12 inhibitors, may influence the endothelial function, as assessed by the Peripheral Arterial Tonometry method (EndoPAT 2000 system (Itamar Medical, Caesarea, Israel), which is a method for evaluating endothelial dysfunction and has been found to positively correlate with flow mediated dilatation (FMD).
This is prospective, randomized study with a crossover design, which will be conducted in patients with CAD under prasugrel maintenance dose (MD) 10mg once a day for at least a 3-month period. At Day 0 (day of randomization) eligible patients will be assigned to either:
- Ticagrelor 90mg twice a day for the next 15 days or
- Prasugrel 10mg once a day for the next 15 days At Day 0 (before treatment onset)patients wiil be subjected to a baseline peripheral arterial tonometry measurement. Measurement will be repeated at Day 15 and then treatment crossover will be performed for the next 15 days (without an intervening washout period). At Day 30 patients will be subjected again to peripheral arterial tonometry assessment. Peripheral blood sample will be taken from the patients in Day 0 for genotyping control.
- Conditions
- Coronary Artery Disease, Endothelial Function
- Being tested
- Ticagrelor, Prasugrel
- Keywords
- ticagrelor, prasugrel, endothelial function
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
PrasugrelDrug
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | Ticagrelor 90mg bid for 15 days Receives: Drug: Ticagrelor; Drug: Prasugrel |
| Prasugrel | Active comparator | Prasugrel 10mg od for 15 days Receives: Drug: Ticagrelor; Drug: Prasugrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive Hyperemia Index (RHI) in the 2 subgroups at the end of 2 periods of treatment
Measured: 15 days
Secondary outcomes (1)
Percentage of patients with endothelial dysfunction (RHI<1.67) at the end of 2 periods of treatment
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionDec 2015
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 Coronary Artery DiseaseStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Alexopoulos, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957540
- Sponsor's protocol ID
- PATRASCARDIOLOGY-16
- Status last verified
- Jan 2017
- First submitted
- 30 Sep 2013
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Xanthopoulou I, Bei I, Bampouri T, Barampoutis N, Moulias A, Davlouros P, Alexopoulos D. Absence of differential effect of ticagrelor versus prasugrel maintenance dose on endothelial function in patients with stable coronary artery disease. Hellenic J Cardiol. 2018 Nov-Dec;59(6):338-343. doi: 10.1016/j.hjc.2017.12.008. Epub 2017 Dec 29.
PubMed 29292242
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effect of Ticagrelor Versus Prasugrel Maintenance Dose on Endothelial Function of Peripheral Vessels in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01957540
- Acronym / sponsor ID
- PATRASCARDIOLOGY-16
- Conditions
- Coronary Artery Disease, Endothelial Function
- Keywords
- ticagrelor, prasugrel, endothelial function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Oct 2013 (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.
Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in overall mortality and thrombotic cardiovascular (CV) events when directly compared to clopidogrel in the PLATO trial, implicating possible pleiotropic actions for the drug. It has been shown that ticagrelor increases adenosine concentration, by interfering with its red blood cells' uptake and by inducing the release of ATP which is then converted to adenosine. Recent studies in healthy volunteers and patients with coronary artery disease (CAD) have shown that ticagrelor increases the coronary blood flow in response to intravenous adenosine administration. Ticagrelor administration, in comparison with other P2Y12 inhibitors, may influence the endothelial function, as assessed by the Peripheral Arterial Tonometry method (EndoPAT 2000 system (Itamar Medical, Caesarea, Israel), which is a method for evaluating endothelial dysfunction and has been found to positively correlate with flow mediated dilatation (FMD).
This is prospective, randomized study with a crossover design, which will be conducted in patients with CAD under prasugrel maintenance dose (MD) 10mg once a day for at least a 3-month period. At Day 0 (day of randomization) eligible patients will be assigned to either:
- Ticagrelor 90mg twice a day for the next 15 days or
- Prasugrel 10mg once a day for the next 15 days At Day 0 (before treatment onset)patients wiil be subjected to a baseline peripheral arterial tonometry measurement. Measurement will be repeated at Day 15 and then treatment crossover will be performed for the next 15 days (without an intervening washout period). At Day 30 patients will be subjected again to peripheral arterial tonometry assessment. Peripheral blood sample will be taken from the patients in Day 0 for genotyping control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: Ticagrelor, Drug: PrasugrelTicagrelor 90mg bid for 15 days |
| Prasugrel | Active comparator | Drug: Ticagrelor, Drug: PrasugrelPrasugrel 10mg od for 15 days |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-74 years old
- Patients with stable CAD who have been submitted(?) to percutaneous intervention for Acute Coronary Syndrome and receiving prasugrel MD 10mg once a day for at least the previous 3 months.
- Patients giving written Informed Consent.
Key exclusion criteria (13 listed)
- Acute Coronary Syndrome
- Contraindication for administration of prasugrel or ticagrelor
- Requirement for oral anticoagulant agents prior to the day 30 visit
- History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months
- Increased risk for bradyarrhythmias, according to the investigator's evaluation
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 | Drug | Prasugrel, Ticagrelor |
| Prasugrel | Drug | Prasugrel, Ticagrelor |
Primary outcome
Reactive Hyperemia Index (RHI) in the 2 subgroups at the end of 2 periods of treatment
Time frame: 15 days
1 secondary outcome
Percentage of patients with endothelial dysfunction (RHI<1.67) at the end of 2 periods of treatment
Time frame: 15 days
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 10 Jan 2017.
- Derived from this study: PubMed 29292242Xanthopoulou I, Bei I, Bampouri T, Barampoutis N, Moulias A, Davlouros P, Alexopoulos D. Absence of differential effect of ticagrelor versus prasugrel maintenance dose on endothelial function in patients with stable coronary artery disease. Hellenic J Cardiol. 2018 Nov-Dec;59(6):338-343. doi: 10.1016/j.hjc.2017.12.008. Epub 2017 Dec 29.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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 Coronary Artery Disease and Endothelial Function, run by University of Patras at 1 site in Greece.
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 13 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 10 Jan 2017. 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 Greece. 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?
Reactive Hyperemia Index (RHI) in the 2 subgroups at the end of 2 periods of treatment (time frame: 15 days). 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 NCT01957540, 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 10 Jan 2017.