- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02032303
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 .
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
-
Rome, Italia, 00100
- Massimo Mancone
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
• Patients with acute coronary syndrome undergoing Percutaneous Coronary Intervention with stent implantation;
- Patients ≥ 18 and ≤ 75 years old.
- Signed informed consent;
Exclusion Criteria:
• 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;
- 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;
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Ticagrelor
Patient randomized to Ticagrelor
|
|
|
Aktiv komparator: Prasugrel
Patient randomized to Prasugrel
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
assessment of coronary flow reserve
Tidsramme: 2 hours after the loading dose
|
2 hours after the loading dose
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Iskemi
- Patologiske prosesser
- Nekrose
- Myokardiskemi
- Hjertesykdommer
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Smerte
- Nevrologiske manifestasjoner
- Sykdom
- Brystsmerter
- Angina pectoris
- Hjerteinfarkt
- Infarkt
- Syndrom
- ST Elevation Hjerteinfarkt
- Akutt koronarsyndrom
- Angina, ustabil
- Ikke-ST forhøyet hjerteinfarkt
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Blodplateaggregasjonshemmere
- Purinergiske P2Y-reseptorantagonister
- Purinergiske P2-reseptorantagonister
- Purinergiske antagonister
- Purinergiske midler
- Ticagrelor
- Prasugrel hydroklorid
Andre studie-ID-numre
- Ticagrelor - Prasugrel
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .