Acute Coronary SyndromePhase 4NCT02032303
Assessment of Coronary Flow Reserve by Doppler Flow WIre in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Differences Between the Loading Dose of Prasugrel and Ticagrelor .
A Phase 4 study testing Assessment of coronary flow reserve, Percutaneous Coronary Intervention and Ticagrelor loading in people with Acute Coronary Syndrome and Non ST Elevation Myocardial Infarction, run by Azienda Policlinico Umberto I at 1 site in Italy.
Trial summary
Study design Investigators aim to perform a prospective, single-center, investigator-initiated, randomized study to compare the Adenosine-induced coronary vasodilatation after the loading dose of Ticagrelor either Prasugrel during the Percutaneous Coronary Intervention. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Non ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction
- What is being tested?
- Assessment of coronary flow reserve, Percutaneous Coronary Intervention and Ticagrelor loading
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2014to Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients with acute coronary syndrome undergoing Percutaneous Coronary Intervention with stent implantation;
- Patients ≥ 18 and ≤ 75 years old.
- Signed informed consent;
Who cannot join
- • Patients with stable angina;
- prior myocardial infarction;
- prior revascularization (Percutaneous Coronary Intervention or coronary artery bypass grafting);
- Ticagrelor contraindications (history of intracranial hemorrhage, active pathological bleeding, severe hepatic impairment);
- Prasugrel contraindications (patients weighing less than 60 kg, patients who had previous stroke or transient ischemic attack, patients aged more than 75 years old);
- major periprocedural complications;
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- suboptimal Percutaneous Coronary Intervention result (residual stenosis > 20%);
- glomerular filtration rate < 30 ml/min or requiring haemodialysis;
- Non-sinus rhythm;
- severe chronic obstructive pulmonary disease;
- requirement for oral anticoagulant;
- risk of bleeding or bradycardic events;
- ejection fraction < 45%;
- Cardiogenic shock;
- Severe left ventricular hypertrophy;
- severe valvular disease;
- diffuse coronary atherosclerosis;
Trial locations and contacts
1 site in 1 country.
massimo mancone contact
About this study
Study design Investigators aim to perform a prospective, single-center, investigator-initiated, randomized study to compare the Adenosine-induced coronary vasodilatation after the loading dose of Ticagrelor either Prasugrel during the Percutaneous Coronary Intervention. Patients with acute coronary syndrome undergoing Percutaneous Coronary Intervention will be enrolled in the study and will be randomized, in a 1:1 ratio, to receive a loading dose of Ticagrelor (180 mg) or Prasugrel (60 mg). In patients with non-ST elevation myocardial infarction these drugs will be administered only when the coronary anatomy will be known, to avoid bleeding due to prasugrel, in patients suitable for coronary artery bypass grafting as recommended by European Society of Cardiology guidelines (Class IB) (10). In patients with ST elevation myocardial infarction, instead, prasugrel and ticagrelor will be administrated before the procedure, according to the European Society of Cardiology guidelines (Class IB) (11). Coronary Flow Reserve will be recorded by intracoronary Doppler Flow Wire before the stent implantation and after the procedure at baseline and 2-minute later adenosine intravenous administration at incremental doses of 50, 80, 110 and 140 ug/Kg/min with 2 minutes interval between infusions.
Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to maximal exercise. Doppler Flow Wire allows to measure this increase expressing it as a ratio between maximal vasodilation and flow at rest. Coronary Flow Reserve is routinely measured in patients with acute coronary syndrome, without an increased risk of adverse events for patients neither adjunctive costs for the National Health System.
Furthermore, Plasma concentrations of Ticagrelor and its main metabolite (AR-C124910XX) will be measured in venous blood collected at the end of the procedure. . In patients requiring a second Percutaneous Coronary Intervention, for example for multivessel disease, all these measures will be repeated in the same manner.
- Conditions
- Acute Coronary Syndrome, Non ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction, Unstable Angina
- Being tested
- Assessment of coronary flow reserve, Percutaneous Coronary Intervention, Ticagrelor loading, Prasugrel loading
- Medical subject headings
- Acute Coronary Syndrome, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of coronary flow reserveProcedure or surgery
Percutaneous Coronary InterventionProcedure or surgery
Ticagrelor loadingDrug
Prasugrel loadingDrug
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Active comparator | Patient randomized to Ticagrelor Receives: Procedure: Assessment of coronary flow reserve; Procedure: Percutaneous Coronary Intervention; Drug: Ticagrelor loading |
| Prasugrel | Active comparator | Patient randomized to Prasugrel Receives: Procedure: Assessment of coronary flow reserve; Procedure: Percutaneous Coronary Intervention; Drug: Prasugrel loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of coronary flow reserve
Measured: 2 hours after the loading dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Policlinico Umberto I
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Mancone, Azienda Policlinico Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032303
- Sponsor's protocol ID
- Ticagrelor - Prasugrel
- Status last verified
- Jan 2014
- First submitted
- 18 Dec 2013
- Last updated
- 10 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coronary Flow Reserve by Doppler Flow WIre in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Differences Between the Loading Dose of Prasugrel and Ticagrelor .
- ClinicalTrials.gov ID
- NCT02032303
- Acronym / sponsor ID
- Ticagrelor - Prasugrel
- Conditions
- Acute Coronary Syndrome, Non ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction, Unstable Angina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Azienda Policlinico Umberto IUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (estimated)
- First posted
- 10 Jan 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.
Study design Investigators aim to perform a prospective, single-center, investigator-initiated, randomized study to compare the Adenosine-induced coronary vasodilatation after the loading dose of Ticagrelor either Prasugrel during the Percutaneous Coronary Intervention. Patients with acute coronary syndrome undergoing Percutaneous Coronary Intervention will be enrolled in the study and will be randomized, in a 1:1 ratio, to receive a loading dose of Ticagrelor (180 mg) or Prasugrel (60 mg). In patients with non-ST elevation myocardial infarction these drugs will be administered only when the coronary anatomy will be known, to avoid bleeding due to prasugrel, in patients suitable for coronary artery bypass grafting as recommended by European Society of Cardiology guidelines (Class IB) (10). In patients with ST elevation myocardial infarction, instead, prasugrel and ticagrelor will be administrated before the procedure, according to the European Society of Cardiology guidelines (Class IB) (11). Coronary Flow Reserve will be recorded by intracoronary Doppler Flow Wire before the stent implantation and after the procedure at baseline and 2-minute later adenosine intravenous administration at incremental doses of 50, 80, 110 and 140 ug/Kg/min with 2 minutes interval between infusions.
Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to maximal exercise. Doppler Flow Wire allows to measure this increase expressing it as a ratio between maximal vasodilation and flow at rest. Coronary Flow Reserve is routinely measured in patients with acute coronary syndrome, without an increased risk of adverse events for patients neither adjunctive costs for the National Health System.
Furthermore, Plasma concentrations of Ticagrelor and its main metabolite (AR-C124910XX) will be measured in venous blood collected at the end of the procedure. . In patients requiring a second Percutaneous Coronary Intervention, for example for multivessel disease, all these measures will be repeated in the same manner.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Active comparator | Procedure: Assessment of coronary flow reserve, Procedure: Percutaneous Coronary Intervention, Drug: Ticagrelor loadingPatient randomized to Ticagrelor |
| Prasugrel | Active comparator | Procedure: Assessment of coronary flow reserve, Procedure: Percutaneous Coronary Intervention, Drug: Prasugrel loadingPatient randomized to Prasugrel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Patients with acute coronary syndrome undergoing Percutaneous Coronary Intervention with stent implantation;
Key exclusion criteria (17 listed)
- • Patients with stable angina;
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 |
|---|---|---|
| Assessment of coronary flow reserve | Procedure or surgery | Prasugrel, Ticagrelor |
| Percutaneous Coronary Intervention | Procedure or surgery | Prasugrel, Ticagrelor |
| Ticagrelor loading | Drug | Ticagrelor |
| Prasugrel loading | Drug | Prasugrel |
Primary outcome
assessment of coronary flow reserve
Time frame: 2 hours after the loading dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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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.
massimo mancone 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 Assessment of coronary flow reserve, Percutaneous Coronary Intervention and Ticagrelor loading in people with Acute Coronary Syndrome and Non ST Elevation Myocardial Infarction, run by Azienda Policlinico Umberto I at 1 site in Italy.
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 17 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 Jan 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 Italy. 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 massimo mancone (00390649979044), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of coronary flow reserve (time frame: 2 hours after the loading dose). 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 Jan 2014.