Coronary Artery DiseaseNCT01957527
Offset of Ticagrelor's Effect on Endothelial Function as Assessed With Peripheral Arterial Tonometry (EndoPAT Assay)
An observational study of 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 80 years
- Conditions the study is for
- Coronary Artery Disease, Endothelial Function
- What is being tested?
- Peripheral arterial tonometry (EndoPAT)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2014to Aug 2015
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary artery disease under ticagrelor maintenance dose, who are about to discontinue ticagrelor, due to completion of 12 months dual antiplatelet therapy.
Who may be able to join
- Age above 18-80 years old
- Patients with Coronary Artery Disease receiving ticagrelor maintenance dose (MD) 90mg x 2 and are about to discontinue the treatment due to the completion of 1 year of dual antiplatelet therapy.
- Patients giving written Informed Consent.
Who cannot join
- Acute Coronary Syndrome
- Foreseeable need for anticoagulant treatment within the next 5 days
- Severe non-regulated with theophylline/aminophylline administration 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 a prospective, observational study, which will be conducted in patients with coronary artery disease subjected to percutaneous coronary intervention (PCI) under ticagrelor maintenance dose (MD) 90mg x 2, who are about to stop treatment, due to completion of 1 year antiplatelet therapy. Eligible patients will be subjected to peripheral arterial tonometry at Day 0 (immediately after receiving the last pill of ticagrelor) and at day 2 and day 5 post study drug discontinuation. Peripheral blood sample will be taken from the patients at Day 0 for genotype analysis.
- Conditions
- Coronary Artery Disease, Endothelial Function
- Being tested
- Peripheral arterial tonometry (EndoPAT)
- Keywords
- ticagrelor, endothelial function, peripheral arterial tonometry
- 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.
Peripheral arterial tonometry (EndoPAT)Device
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor discontinuation | Not described Receives: Device: Peripheral arterial tonometry (EndoPAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive Hyperemia Index (RHI) on Day 0 and on Day 5
Reactive Hyperemia Index (RHI) on Day 0 will be compared to RHI on Day 5
Measured: 5 days
Secondary outcomes (5)
Reactive Hyperemia Index (RHI) on Day 0 and on Day 2
Reactive Hyperemia Index (RHI) on Day 0 will be compared to RHI on Day 2
Measured: 2 days
Reactive Hyperemia Index (RHI) on Day 2 and on Day 5
Reactive Hyperemia Index (RHI) on Day 2 will be compared to RHI on Day 5
Measured: 3 days
The percentage of patients with RHI<1.67 on Day 0 and on Day 5
Measured: 5 days
The percentage of the patients with RHI<1.67 on Day 0 and on Day 2
Measured: 2 days
The percentage of the patients with RHI<1.67 on Day 2 and on Day 5
Measured: 3 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 completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 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
- NCT01957527
- Sponsor's protocol ID
- PATRASCARDIOLOGY-15
- Status last verified
- Aug 2015
- First submitted
- 30 Sep 2013
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Offset of Ticagrelor's Effect on Endothelial Function as Assessed With Peripheral Arterial Tonometry (EndoPAT Assay)
- ClinicalTrials.gov ID
- NCT01957527
- Acronym / sponsor ID
- PATRASCARDIOLOGY-15
- Conditions
- Coronary Artery Disease, Endothelial Function
- Keywords
- ticagrelor, endothelial function, peripheral arterial tonometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 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 a prospective, observational study, which will be conducted in patients with coronary artery disease subjected to percutaneous coronary intervention (PCI) under ticagrelor maintenance dose (MD) 90mg x 2, who are about to stop treatment, due to completion of 1 year antiplatelet therapy. Eligible patients will be subjected to peripheral arterial tonometry at Day 0 (immediately after receiving the last pill of ticagrelor) and at day 2 and day 5 post study drug discontinuation. Peripheral blood sample will be taken from the patients at Day 0 for genotype analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor discontinuation | – | Device: Peripheral arterial tonometry (EndoPAT) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease under ticagrelor maintenance dose, who are about to discontinue ticagrelor, due to completion of 12 months dual antiplatelet therapy.
Key inclusion criteria (3 listed)
- Age above 18-80 years old
- Patients with Coronary Artery Disease receiving ticagrelor maintenance dose (MD) 90mg x 2 and are about to discontinue the treatment due to the completion of 1 year of dual antiplatelet therapy.
- Patients giving written Informed Consent.
Key exclusion criteria (5 listed)
- Acute Coronary Syndrome
- Foreseeable need for anticoagulant treatment within the next 5 days
- Severe non-regulated with theophylline/aminophylline administration chronic obstructive pulmonary disease
- Creatinine Clearance <30ml/min/1.73mm2
- HbA1c > 10mg/dl
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 |
|---|---|---|
| Peripheral arterial tonometry (EndoPAT) | Device | Ticagrelor discontinuation |
Primary outcome
Reactive Hyperemia Index (RHI) on Day 0 and on Day 5
Time frame: 5 days
Reactive Hyperemia Index (RHI) on Day 0 will be compared to RHI on Day 5
5 secondary outcomes
Reactive Hyperemia Index (RHI) on Day 0 and on Day 2
Time frame: 2 days
Reactive Hyperemia Index (RHI) on Day 2 and on Day 5
Time frame: 3 days
The percentage of patients with RHI<1.67 on Day 0 and on Day 5
Time frame: 5 days
The percentage of the patients with RHI<1.67 on Day 0 and on Day 2
Time frame: 2 days
The percentage of the patients with RHI<1.67 on Day 2 and on Day 5
Time frame: 3 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 20 Aug 2015.
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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?
An observational study of 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 5 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 20 Aug 2015. 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.
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) on Day 0 and on Day 5 (time frame: 5 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 20 Aug 2015.