- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01463163
Ticagrelor in Comparison to Prasugrel for Early Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
This is a single-center, randomized, single-blind, investigator-initiated, pharmacodynamic study with a parallel design. Patients with ST elevation myocardial infarction, undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1 ratio to the following treatment groups:
Group Α: Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD)starting 12±6 hours post LD, until Day 5 (5 days after randomization) Group Β: Prasugrel 60 mg LD followed by 10mg x1 MD starting 24 hours post LD, until Day 5 (5 days after randomization).
Platelet reactivity assessment will be performed at randomization (Hour 0) and at 1, 2, 6, 24 hours after randomization, and on Day 5. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and serious adverse events (bleeding, other adverse events)will be performed until Day 5.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
-
-
Achaia
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Rio, Achaia, Grecia, 26500
- Cardiology Department Patras University Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age ≥18 years old
- Patients with STEMI undergoing primary PCI with stenting
- Informed consent obtained in writing
Exclusion Criteria:
- Pregnancy
- Breastfeeding
- Inability to give informed consent or high likelihood of being unavailable until the Day 5
- Prior PCI performed within 30 days prior to randomization
- Cardiogenic shock
- Major periprocedural complications (death, stent thrombosis, vessel perforation, arrhythmias requiring cardioversion, temporary pacemaker insertion or intravenous antiarrhythmic agents, respiratory failure requiring intubation, vascular injury (arteriovenous shunt, retroperitoneal bleeding), major bleeding (need for bood transfusion or drop in haemoglobin post-PCI by ≥ 5 gr/ dl or intracranial bleeding).
- Unsuccessful PCI (residual stenosis > 30% or flow < ΤΙΜΙ 3) or planned staged PCI in the next 5 days after randomization
- Requirement for oral anticoagulant prior to the Day 5 visit
- Current or planned therapy with other thienopyridine class of ADP receptor inhibitors.
- Known hypersensitivity to prasugrel or ticagrelor
- History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
- Other bleeding diathesis, or considered by investigator to be at high risk for bleeding.
- Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
- Thombocytopenia (<100.000 / μL) at randomization
- Anaemia (Hct <30%) at randomization
- Polycytaemia (Hct > 52%) at randomization
- Periprocedural IIb/IIIa inhibitors administration
- Severe allergy to contrast agent, unfractionated heparin, enoxaparin or bivalirudin that cannot be adequately premedicated.
- Recent (< 6 weeks) major surgery or trauma, including GABG.
- Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
- Concomitant oral or IV therapy with strong CY P3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazana vir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3A inducers (rifampin /rifampicin, phenytoin, carbamazepine).
- Increased risk of bradycardiac events.
- Dialysis required.
- Severe uncontrolled chronic obstructive pulmonary disease
- Known severe hepatic impairement
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Prasugrel
Prasugrel 60mg LD followed by 10mg MD starting post 24 hours
|
Prasugrel 60mg LD followed by 10mg x1 MD starting post 24 hours
|
|
Sperimentale: Ticagrelor
Ticagrelor 180mg LD followed by 90mg x2 MD starting post 12±6 hours
|
Ticagrelor 180mg LD followed by 90mg x2 MD starting after 12±6 hours
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Platelet reactivity
Lasso di tempo: 1hour
|
Platelet reactivity Platelet assessed by VerifyNow P2Y12 assay 1 hour post randomization
|
1hour
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Platelet reactivity
Lasso di tempo: 1 hour
|
Platelet Reactivity assessed by Multiplate analyzer assay 1 hour post randomization
|
1 hour
|
|
Platelet reactivity
Lasso di tempo: 2 hours
|
Platelet reactivity assessed by the VerifyNow assay 2 hours post randomization
|
2 hours
|
|
Platelet reactivity
Lasso di tempo: 2 hours
|
Platelet Reactivity assessed by Multiplate analyzer 2 hours post randomization
|
2 hours
|
|
Platelet reactivity
Lasso di tempo: 6 hours
|
Platelet Reactivity assessed by VerifyNow P2Y12 assay 6 hours post randomization
|
6 hours
|
|
Platelet reactivity
Lasso di tempo: 6 hours
|
Platelet Reactivity assessed by Multiplate analyzer 6 hours post randomization
|
6 hours
|
|
Platelet reactivity
Lasso di tempo: 24 hours
|
Platelet Reactivity assessed by VerifyNow P2Y12 assay 24 hours post randomization
|
24 hours
|
|
Platelet reactivity
Lasso di tempo: 24 hours
|
Platelet Reactivity assessed by Multiplate analyzer 24 hours post randomization
|
24 hours
|
|
Platelet reactivity
Lasso di tempo: 5 days
|
Platelet Reactivity assessed by VerifyNow P2Y12 assay 5 days post randomization
|
5 days
|
|
Platelet reactivity
Lasso di tempo: 5 days
|
Platelet Reactivity assessed by Multiplate analyzer 5 days post randomization
|
5 days
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Ischemia
- Processi patologici
- Necrosi
- Ischemia miocardica
- Malattie cardiache
- Malattia cardiovascolare
- Malattie vascolari
- Infarto miocardico
- Infarto
- Infarto del miocardio con sopraslivellamento del tratto ST
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Inibitori dell'aggregazione piastrinica
- Antagonisti del recettore purinergico P2Y
- Antagonisti del recettore purinergico P2
- Antagonisti purinergici
- Agenti purinergici
- Ticagrelor
- Prasugrel cloridrato
Altri numeri di identificazione dello studio
- PATRASCARDIOLOGY-8
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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