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Acute Coronary Syndrome:Phase 4NCT02032290

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 Ticagrelor and Clopidogrel

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The administration of these drugs is realized according to the European Society of Cardiology guidelines. All patients will be pretreated with aspirin 300 mg orally, heparin iv to maintain an activated clotting time of >250 sec, and a loading dose of ticagrelor (180 mg) or clopidogrel (600 mg) immediately before the… Read more about this study

Who is it for?
Ages 18 to 75 years
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 syndromes 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);
  • Clopidogrel and/or Ticagrelor contraindications (history of intracranial hemorrhage, active pathological bleeding, severe hepatic impairment);
  • major periprocedural complications;
  • Glomerular filtration rate < 30 ml/min or requiring haemodialysis;
Show all 16Show fewer
  • 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;
  • indication to coronary artery bypass grafting;
  • diffuse coronary atherosclerosis;

Trial locations and contacts

1 site in 1 country.

massimo mancone, PhD contact

00390649979044

massimomancone@gmail.com

Italy1 site
  • Massimo Mancone

    Rome, Rome, 00100

    00390649970468

    massimo mancone, PhD

Other trials in Italy

About this study

The administration of these drugs is realized according to the European Society of Cardiology guidelines.

All patients will be pretreated with aspirin 300 mg orally, heparin iv to maintain an activated clotting time of >250 sec, and a loading dose of ticagrelor (180 mg) or clopidogrel (600 mg) immediately before the revascularization. The list of assignment to ticagrelor or clopidogrel will be generated by a computer according to a 1:1 randomization. Primary Percutaneous Coronary Intervention will be performed according to standard clinical practice using femoral or radial artery Judkins approach via six or seven French heath insertion. After crossing the target occlusive Lesion, coronary stenting will be performed based on standard practice. Patients subsequently will receive heparin for 48 hr, aspirin 100 mg daily, and clopidogrel (75 mg/day) or ticagrelor (90 mg twice daily) for at least 12 months. Other adjunctive pharmacotherapy in Intensive Care Unit will be administered according to operator discretion. All patients will provide written informed consent before entering the study.

Read more

Before and after the procedure a 12-leads ECG and an echocardiogram will be performed as standard practice. Then, all the pre-, intra-, and post-procedure data patients will be collected in a database.

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 Clopidogrel 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 Clopidogrel (600 mg). 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.

Being tested
Assessment of Coronary Flow Reserve, Percutaneous coronary intervention, ticagrelor loading, Clopidogrel 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

  • Clopidogrel loadingDrug

Study groups in NCT02032290
Study groupRoleWhat they receive
ticagrelorActive comparatorticagrelor: loading dose of 180 mg and maintaining dose of 90 mg twice daily in NSTEMI and STEMI (Class I B) patients;
Receives: Procedure: Assessment of Coronary Flow Reserve; Procedure: Percutaneous coronary intervention; Drug: ticagrelor loading
clopidogrelActive comparatorclopidogrel: loading dose of 600 mg and maintaining dose of 75 mg daily in NSTEMI (Class I B) and STEMI (Class I C) patients.
Receives: Procedure: Assessment of Coronary Flow Reserve; Procedure: Percutaneous coronary intervention; Drug: Clopidogrel loading

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. assessment of coronary flow reserve

    Measured: 2 hours after the loading dose of drugs.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionDec 2014 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02032290
Sponsor's protocol ID
Ticagrelor - Clopidogrel
Status last verified
Jan 2014
First submitted
18 Dec 2013
Last updated
10 Jan 2014
Results posted
No

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 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: 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, PhD (00390649979044, massimomancone@gmail.com), 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 of drugs.). 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.

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