Antiplatelet Agents; Endothelial Function; Pleotropic EffectsPhase 4NCT02261922
Ticagrelor and Endothelial Function
A Phase 4 study testing ticagrelor and prasugrel in people with Antiplatelet Agents; Endothelial Function; Pleotropic Effects, run by Hotel Dieu de France Hospital at 1 site in Lebanon.
Trial summary
To evaluate the effect of ticagrelor on endothelial function as measured by flow mediated dilation of the brachial artery. This will be compared to prasugrel. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Antiplatelet Agents; Endothelial Function; Pleotropic Effects
- What is being tested?
- ticagrelor and prasugrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteLebanon
- Study dates
- Oct 2014to Nov 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Prior MI > 1 year old
- Prior PCI > 1 year old
- Prior CABG > 3 months old
- Known lesion causing more than 50% stenosis on coronary angiography
Who cannot join
- Acute coronary syndrome within the last 6 months
- Any history of bleeding
- Age > 75 years
- Weight < 65 kg
- Prior stroke or TIA
- Platelet count < 100,000
Show all 9Show fewer
- Hemoglobin < 11 mg/dL
- Patients who have received ticagrelor, prasugrel or clopidogrel in the 3 months that preceded randomization
- Patients who are taking anti-thrombotic therapy
Trial locations and contacts
1 site in 1 country.
Rabih Azar, MD, MPH contact
Lebanon1 site, 1 recruiting
- Recruiting
Hotel Dieu de France Hospital
El Achrafiyé, Beirut, Beirut
Rabih R Azar, MD, MPH, +9611615300 ext. 9408, razar@usj.edu.lb
About this study
Official title: A Prospective Randomized Double Blind Study to Evaluate the Effect of Ticagrelor on Endothelial Function
To evaluate the effect of ticagrelor on endothelial function as measured by flow mediated dilation of the brachial artery. This will be compared to prasugrel.
Read the detailed description
Objective:
Demonstrate an improvement in endothelial function with ticagrelor
Introduction and hypothesis:
Ticagrelor and prasugrel are 2 new platelet antagonists. Both are superior to clopidogrel when used in acute coronary syndromes. However, only ticagrelor reduced cardiovascular mortality by almost 20%. Prasugrel reduced the composite clinical end point of cardiovascular mortality, myocardial infarction and stroke, but did not decrease mortality. The exact mechanism of mortality reduction with ticagrelor is unclear.
Some side effects of ticagrelor, such as brady-arrhythmias and dyspnea may be related to adenosine release. It is thus possible, that this drug may liberate significant amount of adenosine. Prior studies have demonstrated that adenosine has beneficial effects on the endothelial function and that it improves the outcome of patient with acute coronary syndromes.
It is thus possible that ticagrelor may improve endothelial function through an adenosine like effect. This effect is independent from platelet inhibition.
Prasugrel has the same platelet inhibition effect compared to ticagrelor, but our hypothesis is that it does not have an adenosine like effect and thus does not improve endothelial function.
Study design:
This is a prospective, randomized, double blind, cross-over study comparing 2 new platelet inhibitors that have the same potency: ticagrelor and prasugrel.
Patients with stable coronary artery disease will be randomized to one of these 2 drugs. Patients will receive one of the 2 drugs for a period of 8 +/- 2 days, they will then stop the drug for a period of 14 +/- 2 days, and they will then cross over and receive the other drug for a period of 8 +/- 2 days.
All patients will have the following measurements:
- Flow mediated Dilation (FMD) of the brachial artery
- Platelet aggregation in response to ADP
All measurements will be done at:
- Baseline 1 (prior to starting drug 1)
- At 8 +/- 2 days (peak effect of drug 1)
- Baseline 2 (at 14+/- 2 days; after washout and prior to starting drug 2)
- At 8 +/- 2 days after baseline 2 (peak effect of drug 2)
Measure of FMD of the brachial artery:
It will be performed according to the Academic Medical Center of Amsterdam pre-established protocol.
Measure of platelet aggregation:
It will be performed with the multiplate aggregometer
Study End-Points:
- Primary: change in FMD before and after each of the 2 drugs
- Secondary: Change in platelet aggregation before and after each of the 2 drugs
- Possible another secondary end-point: Change in NO activity in the blood before and after each of the 2 drugs
- Being tested
- ticagrelor, prasugrel
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 treatment Receives: Drug: ticagrelor |
| prasugrel | Active comparator | prasugrel treatment Receives: Drug: prasugrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
flow mediated dilation of the brachial artery
Measured: 8 +/- 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiplatelet Agents; Endothelial Function; Pleotropic EffectsStudies 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
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hotel Dieu de France Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabih Azar, Hotel Dieu de France Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261922
- Sponsor's protocol ID
- FM240
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2014
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Double Blind Study to Evaluate the Effect of Ticagrelor on Endothelial Function
- ClinicalTrials.gov ID
- NCT02261922
- Acronym / sponsor ID
- FM240
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hotel Dieu de France HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 10 Oct 2014 (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 evaluate the effect of ticagrelor on endothelial function as measured by flow mediated dilation of the brachial artery. This will be compared to prasugrel.
Detailed description
Objective:
Demonstrate an improvement in endothelial function with ticagrelor
Introduction and hypothesis:
Ticagrelor and prasugrel are 2 new platelet antagonists. Both are superior to clopidogrel when used in acute coronary syndromes. However, only ticagrelor reduced cardiovascular mortality by almost 20%. Prasugrel reduced the composite clinical end point of cardiovascular mortality, myocardial infarction and stroke, but did not decrease mortality. The exact mechanism of mortality reduction with ticagrelor is unclear.
Some side effects of ticagrelor, such as brady-arrhythmias and dyspnea may be related to adenosine release. It is thus possible, that this drug may liberate significant amount of adenosine. Prior studies have demonstrated that adenosine has beneficial effects on the endothelial function and that it improves the outcome of patient with acute coronary syndromes.
It is thus possible that ticagrelor may improve endothelial function through an adenosine like effect. This effect is independent from platelet inhibition.
Prasugrel has the same platelet inhibition effect compared to ticagrelor, but our hypothesis is that it does not have an adenosine like effect and thus does not improve endothelial function.
Study design:
This is a prospective, randomized, double blind, cross-over study comparing 2 new platelet inhibitors that have the same potency: ticagrelor and prasugrel.
Patients with stable coronary artery disease will be randomized to one of these 2 drugs. Patients will receive one of the 2 drugs for a period of 8 +/- 2 days, they will then stop the drug for a period of 14 +/- 2 days, and they will then cross over and receive the other drug for a period of 8 +/- 2 days.
All patients will have the following measurements:
- Flow mediated Dilation (FMD) of the brachial artery
- Platelet aggregation in response to ADP
All measurements will be done at:
- Baseline 1 (prior to starting drug 1)
- At 8 +/- 2 days (peak effect of drug 1)
- Baseline 2 (at 14+/- 2 days; after washout and prior to starting drug 2)
- At 8 +/- 2 days after baseline 2 (peak effect of drug 2)
Measure of FMD of the brachial artery:
It will be performed according to the Academic Medical Center of Amsterdam pre-established protocol.
Measure of platelet aggregation:
It will be performed with the multiplate aggregometer
Study End-Points:
- Primary: change in FMD before and after each of the 2 drugs
- Secondary: Change in platelet aggregation before and after each of the 2 drugs
- Possible another secondary end-point: Change in NO activity in the blood before and after each of the 2 drugs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ticagrelor | Experimental | Drug: ticagrelorticagrelor treatment |
| prasugrel | Active comparator | Drug: prasugrelprasugrel treatment |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - Prior MI > 1 year old
- Prior PCI > 1 year old
- Prior CABG > 3 months old
- Known lesion causing more than 50% stenosis on coronary angiography
Key exclusion criteria (9 listed)
- Acute coronary syndrome within the last 6 months
- Any history of bleeding
- Age > 75 years
- Weight < 65 kg
- Prior stroke or TIA
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 | ticagrelor |
| prasugrel | Drug | prasugrel |
Primary outcome
flow mediated dilation of the brachial artery
Time frame: 8 +/- 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2014.
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.
Rabih Azar, MD, MPH contact
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 Antiplatelet Agents; Endothelial Function; Pleotropic Effects, run by Hotel Dieu de France Hospital at 1 site in Lebanon.
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 9 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 10 Oct 2014. 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 Lebanon. 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 Rabih Azar, MD, MPH (razar@usj.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
flow mediated dilation of the brachial artery (time frame: 8 +/- 2 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 10 Oct 2014; AzTrials last refreshed its copy on 28 Oct 2026.