- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02065479
A Pharmacodynamic Study Comparing Prasugrel Versus Ticagrelor in Patients Undergoing PCI With CYP2C19 Loss-of-function:
27 augusti 2020 uppdaterad av: University of Florida
A Pharmacodynamic Study Comparing Prasugrel Versus Ticagrelor in Patients With Coronary Artery Disease Undergoing PCI With CYP2C19 Loss-of-function Genotypes: A Feasibility Study With Point-of-care Pharmacodynamic and Genetic Testing
Numerous studies have shown that pharmacodynamics (PD) response profiles vary among clopidogrel treated patients and that individuals with reduced response have an increased risk of recurrent ischemic events.
There are multiple factors contributing to clopidogrel response variability, including genetic variations of the cytochrome P450 (CYP) 2C19 enzyme.
In particular, loss-of-function (LOF) alleles of the CYP2C19 enzyme reduce transformation of clopidogrel pro-drug into its active metabolite.
Thus, patients carrying LOF alleles have lower levels of clopidogrel's active metabolite as well as diminished platelet inhibition, which translates into an increased rate of adverse cardiovascular events, particularly in the setting of percutaneous coronary intervention (PCI).
Prasugrel and ticagrelor are novel generation P2Y12 receptor inhibitors characterized by greater PD potency and reduced ischemic event rates compared with clopidogrel, and are not affected by CYP2C19 LOF polymorphisms.
However, to date there are limited head-to-head PD comparisons between these two new P2Y12 receptors blockers, and there are no studies assessing on how these agents behave among CYP2C19 LOF carriers.
The aim of the present study is to compare the PD effects of prasugrel versus ticagrelor in patients undergoing PCI with CYP2C19 LOF alleles using the novel point-of-care genetic testing Spartan RX-CYP2C19 which permits accurate and rapid identification of CYP2C19 genetic status.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Clopidogrel is the most broadly utilized platelet P2Y12 receptor inhibitor.
However, numerous studies have shown that pharmacodynamics (PD) response profiles vary among clopidogrel treated patients and that individuals with reduced response have an increased risk of recurrent ischemic events.
There are multiple factors contributing to clopidogrel response variability.
Among these, genetic variations of the cytochrome P450 (CYP) 2C19 enzyme, a key contributor to clopidogrel metabolism, have been involved.
In particular, loss-of-function (LOF) alleles of the CYP2C19 enzyme reduce transformation of clopidogrel pro-drug into its active metabolite.
Thus, patients carrying LOF alleles have lower levels of clopidogrel's active metabolite as well as diminished platelet inhibition, which translates into an increased rate of adverse cardiovascular events, particularly in the setting of percutaneous coronary intervention (PCI).
Because of these findings, drug regulating authorities have provided a boxed warning on the product label of clopidogrel on the potential for reduced efficacy of clopidogrel among CYP2C19 LOF carriers and suggested considering alternative antiplatelet therapies for these individuals.
Prasugrel and ticagrelor are novel generation P2Y12 receptor inhibitors characterized by greater PD potency and reduced ischemic event rates compared with clopidogrel, and are not affected by CYP2C19 LOF polymorphisms.
However, to date there are limited head-to-head PD comparisons between these two new P2Y12 receptors blockers, and there are no studies assessing on how these agents behave among CYP2C19 LOF carriers.
Tailoring antiplatelet therapy according to results of genetic testing has been limited in real world clinical practice because of not having readily accessible results of individual's genetic makeup.
The aim of the present study is to compare the PD effects of prasugrel versus ticagrelor in patients undergoing PCI with CYP2C19 LOF alleles using the novel point-of-care genetic testing Spartan RX-CYP2C19 which permits accurate and rapid identification of CYP2C19 genetic status.
Studietyp
Interventionell
Inskrivning (Faktisk)
65
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Florida
-
Jacksonville, Florida, Förenta staterna, 32209
- University of Florida
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 74 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion criteria:
- Patients scheduled for left heart catheterization and undergoing PCI
- Age 18-75 years
- On aspirin (81mg) or aspirin (81mg) and clopidogrel (75mg/day)
- Presence of at least one 2C19 LOF allele
Exclusion criteria:
- Known allergies to aspirin, prasugrel, ticagrelor, or clopidogrel
- Age >75 years
- Weight <60kg
- Considered at high risk for bleeding
- History of ischemic or hemorrhagic stroke or transient ischemic attack
- Known severe hepatic dysfunction
- On treatment with oral anticoagulant therapy (Vitamin K antagonists, dabigatran, apixaban, rivaroxaban)
- Use of glycoprotein IIb/IIIa inhibitors (abciximab, eptifibatide, tirofiban)
- Blood dyscrasia or bleeding diathesis
- Platelet count <80x106/mL
- Hemoglobin <10 g/dL.
- Active bleeding or hemodynamic instability
- Creatinine Clearance <30 mL/minute
- Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection.
- Current treatment with drugs interfering with 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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Ticagrelor
The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.
|
Comparison of platelet reactivity between prasugrel and ticagrelor
Andra namn:
|
|
Experimentell: Prasugrel
The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.
|
Comparison of platelet reactivity between prasugrel and ticagrelor
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Platelet Reactivity
Tidsram: 24 hours post loading dose
|
The primary endpoint is P2Y12 reaction unit (PRU) measured by the Verify Now P2Y12 assay 24hours/hospital discharge post randomization to prasugrel vs ticagrelor.
PRU is is an arbitrary unit of measure to assess ADP-induced platelet aggregation.
|
24 hours post loading dose
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2014
Primärt slutförande (Faktisk)
22 april 2019
Avslutad studie (Faktisk)
22 april 2019
Studieregistreringsdatum
Först inskickad
12 februari 2014
Först inskickad som uppfyllde QC-kriterierna
14 februari 2014
Första postat (Uppskatta)
19 februari 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 september 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 augusti 2020
Senast verifierad
1 augusti 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hjärtsjukdom
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Arterioskleros
- Arteriella ocklusiva sjukdomar
- Kranskärlssjukdom
- Myokardischemi
- Kranskärlssjukdom
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Trombocytaggregationshämmare
- Purinerga P2Y-receptorantagonister
- Purinerga P2-receptorantagonister
- Purinerga antagonister
- Purinerga medel
- Ticagrelor
- Prasugrel hydroklorid
Andra studie-ID-nummer
- UFJ 2014-12
- IRB201702750 (Annan identifierare: UF IRB)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
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