Fractional Flow ReservePhase 4NCT02108808
Effect of Ticagrelor on Fractional Flow Reserve
A Phase 4 study testing Ticagrelor and Prasugrel or Clopidogrel in people with Fractional Flow Reserve, run by University of Patras at 1 site in Greece.
Trial summary
Fractional flow reserve (FFR) is an established invasive method for assessing the physiological significance of coronary artery stenosis. Adenosine, an important endogenous regulator of coronary blood flow during both stress and ischemia, is widely used to achieve conditions of stable hyperemia required for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fractional Flow Reserve
- What is being tested?
- Ticagrelor and Prasugrel or Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2014to Oct 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Patients subjected to clinically indicated coronary angiography with at least one 50%-90% stenosis at 1 major epicardial vessel (by visual assessment) amenable to percutaneous coronary intervention.
- Ticagrelor naive patients
- Written informed consent
Who cannot join
- History of coronary artery bypass surgery
- Acute myocardial infarction within the previous 5 days
- Known allergy to adenosine, ticagrelor, prasugrel or clopidogrel
- Prior intracranial hemorrhage
- Hemodialysis or creatinine clearance < 30ml/h
- Moderate/severe hepatic failure
Show all 16Show fewer
- Active bleeding, or at increased risk of bleeding
- Left ventricular ejection fraction <40%
- Primary myocardial or valvular disease
- Contraindication to adenosine
- Angiographically visible thrombus at a target lesion, extremely tortuous coronary arteries, severely calcified lesions, left main disease, anatomy suitable for coronary artery bypass surgery
- Previous q wave myocardial infarction in the area of target vessel
- Severe left ventricular hypertrophy
- Severe valvular heart disease
- Heart failure as defined by New York Heart Association class III or IV 16.Hypotension (blood pressure <90 mm Hg)
- 17.Significant arrhythmia (e.g. excessive premature ventricular contractions or atrial fibrillation), tachycardia (heart rate >120 beats/min), bradycardia (<50 beats/min), increased risk for bradycardia 18.Caffeine consumption or cigarette smoking within the previous 24 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Effect of Ticagrelor vs Prasugrel or Clopidogrel Loading on Fractional Flow Reserve
Fractional flow reserve (FFR) is an established invasive method for assessing the physiological significance of coronary artery stenosis. Adenosine, an important endogenous regulator of coronary blood flow during both stress and ischemia, is widely used to achieve conditions of stable hyperemia required for measurement of FFR.
Studies in healthy volunteers and in patients with acute coronary syndrome (ACS) post percutaneous coronary intervention (PCI) receiving ticagrelor revealed a differential coronary blood flow velocity response during increasing doses of adenosine compared to placebo or prasugrel treated subjects, respectively. It has also been demonstrated that patients treated with ticagrelor have increased plasma adenosine levels. Therefore, it has been hypothesized that the degree of hyperemia obtained with adenosine infusion may be greater in patients on ticagrelor than that obtained in patients taking clopidogrel or prasugrel. If this proves to be true, it would lead to a lower FFR value with possible important clinical implications in ticagrelor receiving patients in need for FFR measurement.
This is a prospective, single center, randomized study of parallel design. Consecutive ticagrelor naive patients who are referred for coronary angiography and have an angiographically moderate to severe de novo stenosis (>50% and <90% diameter by visual assessment) in at least one major epicardial coronary artery amenable to PCI are candidates for this study. Patients after informed consent will be randomized (hour 0) to receive immediately post FFR (with adenosine iintravenous infusion at 140 μg/Kg/min for a 3 minute period) either ticagrelor 180mg loading dose or prasugrel 60mg/clopidogrel 600mg loading dose (as clinically indicated). FFR examination will be repeated 2 hours post loading dose.
- Conditions
- Fractional Flow Reserve
- Being tested
- Ticagrelor, Prasugrel or Clopidogrel
- Keywords
- FFR, adenosine, Ticagrelor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Prasugrel or ClopidogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel or Clopidogrel | Active comparator | Prasugrel 60mg or Clopidogrel 600mg loading dose, as clinically indicated Receives: Drug: Prasugrel or Clopidogrel |
| Ticagrelor | Experimental | Ticagrelor 180mg loading dose Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
% relative change in steady hyperemia FFR (sFFR)
Steady hyperemia FFR (sFFR) is defined as the FFR value attained during stable hyperemia (as assessed by offline visual inspection of the 3-min hemodynamic trace) (sFFR post drug - sFFR pre drug)*100/sFFR pre drug between the 2 treatment arms
Measured: 2 hours
Secondary outcomes (5)
% relative change in peak hyperemia FFR (pFFR)
Peak hyperemia FFR is defined as the lowest FFR measurement during the first 60 sec of adenosine infusion (pFFR post drug - pFFR pre drug)*100/pFFR pre drug between the 2 treatment arms
Measured: 2 hours
% relative change in lowest FFR (lFFR)
Lowest FFR (lFFR) is defined as the value provided by the automated FFR console (lFFR post drug - lFFR pre drug)*100/lFFR pre drug between the 2 treatment arms
Measured: 2 hours
% relative change in time to peak FFR (in seconds)
(time to pFFR post drug - time to pFFR pre drug)*100/time to pFFR pre drug between the 2 treatment arms
Measured: 2 hours
% relative change in time to lowest FFR
(time to lFFR post drug - time to lFFR pre drug)*100/time to lFFR pre drug between the 2 treatment arms
Measured: 2 hours
% relative change in area under the curve (AUC) of the FFR trace
(AUC FFR post drug - AUC FFR pre drug)*100/AUC FFR pre drug between the 2 treatment arms
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractional Flow ReserveStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 76 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
- NCT02108808
- Sponsor's protocol ID
- PATRAS CARDIOLOGY 18
- Status last verified
- Jan 2015
- First submitted
- 4 Apr 2014
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effect of Ticagrelor vs Prasugrel or Clopidogrel Loading on Fractional Flow Reserve
- ClinicalTrials.gov ID
- NCT02108808
- Acronym / sponsor ID
- PATRAS CARDIOLOGY 18
- Conditions
- Fractional Flow Reserve
- Keywords
- FFR, adenosine, Ticagrelor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 9 Apr 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.
Fractional flow reserve (FFR) is an established invasive method for assessing the physiological significance of coronary artery stenosis. Adenosine, an important endogenous regulator of coronary blood flow during both stress and ischemia, is widely used to achieve conditions of stable hyperemia required for measurement of FFR.
Studies in healthy volunteers and in patients with acute coronary syndrome (ACS) post percutaneous coronary intervention (PCI) receiving ticagrelor revealed a differential coronary blood flow velocity response during increasing doses of adenosine compared to placebo or prasugrel treated subjects, respectively. It has also been demonstrated that patients treated with ticagrelor have increased plasma adenosine levels. Therefore, it has been hypothesized that the degree of hyperemia obtained with adenosine infusion may be greater in patients on ticagrelor than that obtained in patients taking clopidogrel or prasugrel. If this proves to be true, it would lead to a lower FFR value with possible important clinical implications in ticagrelor receiving patients in need for FFR measurement.
This is a prospective, single center, randomized study of parallel design. Consecutive ticagrelor naive patients who are referred for coronary angiography and have an angiographically moderate to severe de novo stenosis (>50% and <90% diameter by visual assessment) in at least one major epicardial coronary artery amenable to PCI are candidates for this study. Patients after informed consent will be randomized (hour 0) to receive immediately post FFR (with adenosine iintravenous infusion at 140 μg/Kg/min for a 3 minute period) either ticagrelor 180mg loading dose or prasugrel 60mg/clopidogrel 600mg loading dose (as clinically indicated). FFR examination will be repeated 2 hours post loading dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prasugrel or Clopidogrel | Active comparator | Drug: Prasugrel or ClopidogrelPrasugrel 60mg or Clopidogrel 600mg loading dose, as clinically indicated |
| Ticagrelor | Experimental | Drug: TicagrelorTicagrelor 180mg loading dose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years
- Patients subjected to clinically indicated coronary angiography with at least one 50%-90% stenosis at 1 major epicardial vessel (by visual assessment) amenable to percutaneous coronary intervention.
- Ticagrelor naive patients
- Written informed consent
Key exclusion criteria (16 listed)
- History of coronary artery bypass surgery
- Acute myocardial infarction within the previous 5 days
- Known allergy to adenosine, ticagrelor, prasugrel or clopidogrel
- Prior intracranial hemorrhage
- Hemodialysis or creatinine clearance < 30ml/h
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 or Clopidogrel | Drug | Prasugrel or Clopidogrel |
Primary outcome
% relative change in steady hyperemia FFR (sFFR)
Time frame: 2 hours
Steady hyperemia FFR (sFFR) is defined as the FFR value attained during stable hyperemia (as assessed by offline visual inspection of the 3-min hemodynamic trace) (sFFR post drug - sFFR pre drug)*100/sFFR pre drug between the 2 treatment arms
5 secondary outcomes
% relative change in peak hyperemia FFR (pFFR)
Time frame: 2 hours
% relative change in lowest FFR (lFFR)
Time frame: 2 hours
% relative change in time to peak FFR (in seconds)
Time frame: 2 hours
% relative change in time to lowest FFR
Time frame: 2 hours
% relative change in area under the curve (AUC) of the FFR trace
Time frame: 2 hours
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 6 Jan 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?
A Phase 4 study testing Ticagrelor and Prasugrel or Clopidogrel in people with Fractional Flow Reserve, 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 4 inclusion and 16 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 6 Jan 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.
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?
% relative change in steady hyperemia FFR (sFFR) (time frame: 2 hours). 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 Jan 2015.