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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01406483
Platelet Reactivity in Patients on a Thienopyridine and Awaiting Coronary Artery Bypass Grafting (Serial CABG)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The recent emergence of platelet reactivity testing as a potential option for evaluating the degree of platelet inhibition promises to add another level of understanding to our concept of CABG-related bleeding. There is an emerging literature that links high levels of platelet reactivity with adverse clinical events, primarily in patients on clopidogrel.
For example, studies of the VerifyNow P2Y12 platelet function assay have shown that Platelet Reactivity Units (PRU) > 235-240 in patients on clopidogrel therapy appears to predict cardiovascular events.15,16 There is a paucity of literature, however, on the use of platelet reactivity testing to predict bleeding events and complications. In other words, if excessively high levels of platelet reactivity predict ischemic events, do excessively low levels of platelet reactivity predict bleeding events? This is an especially relevant question, given the emergence of prasugrel as a therapeutic option.
The investigators therefore propose an exploratory cohort study of patients receiving a thienopyridine (clopidogrel or prasugrel) and undergoing CABG, in order to describe levels of platelet reactivity in such patients by using a variety of platelet function tests.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients ≥ 18 years old from both genders.
- Taking maintenance thienopyridine therapy within 5 days of surgery OR received a loading dose of thienopyridine therapy within 48 hours of surgery for CABG.
- Referred for CABG (which is scheduled to be performed during the current admission).
Exclusion Criteria:
- Known allergies to aspirin, clopidogrel, or prasugrel.
- Use of a glycoprotein (GP) IIb/IIIa inhibitor within 8 hours of initial platelet reactivity testing.
- Patient known to be pregnant or lactating.
- Patient with known history of bleeding diathesis or currently active bleeding.
- Platelet count <100,000/mm the day of initial blood draw.
- Hematocrit <25% the day of initial blood draw.
- On warfarin therapy at the time of initial blood draw.
- Known blood transfusion within the preceding 10 days of the blood draw.
- Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
- Plan for patient to be discharged before undergoing CABG.
- Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Altro: CABG
|
Platelet reactivity, as measured by the Chrono-log Lumi-Aggregometer, VerifyNow P2Y12 assay, and Vasodilator Stimulated Phosphoprotein (VASP) flow cytometry assay.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Serial levels of platelet reactivity, as assessed with the Chrono-log Lumi-Aggregometer
Lasso di tempo: Duration of hospital stay; average hospital stay of 1 week
|
Serial levels of platelet reactivity, as assessed with the Chrono-log Lumi-Aggregometer, which measures levels of light transmittance after stimulation with ADP to estimate levels of platelet aggregation
|
Duration of hospital stay; average hospital stay of 1 week
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Perioperative rates of bleeding complications
Lasso di tempo: Duration of hospital stay; average hospital stay of 1 week
|
Perioperative rates of bleeding complications:
|
Duration of hospital stay; average hospital stay of 1 week
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Serial levels of platelet reactivity, as assessed with the VerifyNow P2Y12 assay
Lasso di tempo: Duration of hospital stay; average hospital stay of 1 week
|
Serial levels of platelet reactivity, as assessed with the VerifyNow P2Y12 assay, which measures platelet reactivity units (PRUs)
|
Duration of hospital stay; average hospital stay of 1 week
|
Serial levels of platelet reactivity, as assessed with the Vasodilator Stimulated Phosphoprotein (VASP) assay
Lasso di tempo: Duration of hospital stay; average hospital stay of 1 week
|
Serial levels of platelet reactivity, as assessed with the Vasodilator Stimulated Phosphoprotein (VASP) assay, which measures percentage of platelet reactivity inhibition (PRI) by flow cytometry of the VASP-P protein
|
Duration of hospital stay; average hospital stay of 1 week
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
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 (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Serial CABG
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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