- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01852214
Pharmacodynamic Effect of Prasugrel vs. Ticagrelor in Diabetes
22. august 2016 oppdatert av: University of Florida
A Pharmacodynamic Comparison of Prasugrel vs. Ticagrelor in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease
Patients with diabetes mellitus (DM) have an increased risk of adverse atherothrombotic events.
This may be in part attributed to the fact that these patients have reduced response to oral antiplatelet medications, in particular the P2Y12 receptor inhibitor clopidogrel, used for secondary prevention of ischemic events.
Prasugrel and ticagrelor are recently approved P2Y12 receptor inhibitors which, compared with clopidogrel, have more potent antiplatelet effects.
Head-to-head comparisons between the two drugs are lacking.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Patients with diabetes mellitus (DM) have an increased risk of adverse atherothrombotic events.
This may be in part attributed to the fact that these patients have reduced response to oral antiplatelet medications, in particular the P2Y12 receptor inhibitor clopidogrel, used for secondary prevention of ischemic events.
Upregulation of platelet P2Y12 receptor mediated signaling has been shown in DM patients and may contribute to these pharmacodynamic observations, suggesting the need for more potent P2Y12 inhibiting strategies in these patients.
Prasugrel and ticagrelor are recently approved P2Y12 receptor inhibitors which, compared with clopidogrel, have more potent antiplatelet effects.
Therefore, prasugrel and ticagrelor represent attractive treatment options for patients with DM.
This is also supported by the DM sub-group analysis of the pivotal TRITON-TIMI 38 (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis in Myocardial Infarction) and PLATO (Platelet Inhibition and Patient Outcomes) trials, which have led to approval of prasugrel and ticagrelor, respectively.
Although results of these sub-group analysis suggest that prasugrel is associated with an enhanced benefit in DM patients, while ticagrelor effects in DM patients are consistent with the overall study population, only head-to-head comparisons between the two drugs can elucidate if these exert differential effects on platelets from DM patients.
However, the pharmacodynamic studies comparing prasugrel with ticagrelor in DM patients are lacking.
The ever growing DM population at high risk of recurrent atherothrombotic events underscores the need to define antiplatelet treatment strategies leading to more optimal platelet inhibition in these patients.
Studietype
Intervensjonell
Registrering (Faktiske)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Florida
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Jacksonville, Florida, Forente stater, 32209
- University of Florida
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 74 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients with known (angiographically documented) CAD.
- On maintenance treatment with aspirin (81 mg per day) for at least 1-month as per standard of care.
- Type 2 DM on treatment with oral hypoglycemic agents and/or insulin.
- Age between 18 and 74 years old.
Exclusion Criteria:
- History of stroke, transient ischemic attack or intracranial bleeding.
- On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor).
- Known allergies to aspirin, ticlopidine, clopidogrel, prasugrel, ticagrelor.
- Weight <60kg.
- On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran).
- Blood dyscrasia or bleeding diathesis.
- Platelet count <80x106/mL.
- Hemoglobin <10 g/dL.
- Active bleeding or hemodynamic instability.
- Creatinine Clearance <30 mL/minute.
- Baseline ALT >2.5 times the upper limit of normal.
- Hb A1c ≥ 10 mg/dL within 3 months.
- Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection.
- Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin.
Pregnant females*.
- Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Prasugrel first, then ticagrelor
Patients randomized to prasugrel will receive prasugrel loading dose followed by maintenance dose.
Randomized treatment will be maintained for 1-week (7±2 days).
After completion of the 1-week treatment period, patients will discontinued the study medications for 2-4 weeks (wash-out period) and then will cross over to the alternate treatment (ticagrelor), which will be administered for 1-week.
|
Patients receiving prasugrel will be treated with 60mg loading dose and 10mg maintenance dose
Andre navn:
Patients receiving ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose
Andre navn:
|
Aktiv komparator: Ticagrelor first, then prasugrel
Patients randomized to ticagrelor will receive prasugrel loading dose followed by maintenance dose.
Randomized treatment will be maintained for 1-week (7±2 days).
After completion of the 1-week treatment period, patients will discontinued the study medications for 2-4 weeks (wash-out period) and then will cross over to the alternate treatment (prasugrel), which will be administered for 1-week.
|
Patients receiving prasugrel will be treated with 60mg loading dose and 10mg maintenance dose
Andre navn:
Patients receiving ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
P2Y12 Reaction Units
Tidsramme: 1 week
|
The primary endpoint is the comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel).
Treatment effects were evaluated comparing PRU observed in the overall patient population after prasugrel treatment with those achieved after ticagrelor regardless of the sequence.
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1 week
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
P2Y12 Reaction Units
Tidsramme: 2 hours
|
Comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel)
|
2 hours
|
Platelet Reactivity Index
Tidsramme: 1 week
|
The comparison of the platelet reactivity index (PRI) values determined by vasodilator-stimulated phosphoprotein (VASP) between both treatments (ticagrelor or prasugrel).
VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies.
A low PRI is indicative of high platelet inhibition.
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1 week
|
Platelet Reactivity Index
Tidsramme: 2 hours
|
The comparison of the platelet reactivity index (PRI) values determined by vasodilator-stimulated phosphoprotein (VASP) between both treatments (ticagrelor or prasugrel).
VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies.
A low PRI is indicative of high platelet inhibition.
|
2 hours
|
Samarbeidspartnere og etterforskere
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Sponsor
Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2013
Primær fullføring (Faktiske)
1. juli 2015
Studiet fullført (Faktiske)
1. august 2015
Datoer for studieregistrering
Først innsendt
8. mai 2013
Først innsendt som oppfylte QC-kriteriene
10. mai 2013
Først lagt ut (Anslag)
13. mai 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. oktober 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. august 2016
Sist bekreftet
1. juni 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Hjertesykdommer
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Glukosemetabolismeforstyrrelser
- Metabolske sykdommer
- Arteriosklerose
- Arterielle okklusive sykdommer
- Sykdommer i det endokrine systemet
- Koronararteriesykdom
- Myokardiskemi
- Koronar sykdom
- Sukkersyke
- 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
- UFJ 2011-184
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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