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- Register voor klinische proeven in de VS.
- Klinische proef NCT01338909
Prasugrel in Comparison to Clopidogrel for Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI) (PRO-GR-4)
Prasugrel in Comparison to Clopidogrel for Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)and Presenting With High Platelet Reactivity, as Assessed With a Point of Care Assay, After 600mg Clopidogrel Loading Dose
This is a single-center, randomized, single-blind, investigator-initiated, pharmacological study with a parallel design. Patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention and presenting high platelet reactivity as assessed with the Verify Now P2Y12 assay-Accumetrics(Platelet Reactivity Units -PRU≥235) at 2 hours post-clopidogrel 600mg LD (Day 0), as assessed with the Verify Now P2Y12 assay, will be randomized after informed consent, in a 1:1 ratio to the following treatment groups:
Group Α: Clopidogrel 150mg per day,starting from Day 1 until Day 5 (5 days after randomization) Group Β: Prasugrel 60 mg immediate loading (on Day 0) followed by 10mg/day starting from Day 1 until Day 5 (5 days after randomization).
Platelet reactivity assessment will be performed 2 hours after randomization (Day 0), 24 h after randomization (Day 1) 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Patras, Griekenland, 26500
- Patras University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Age ≥18 years old
- Patients with STEMI undergoing primary PCI with stenting
- Platelet reactivity in PRU ≥235 2 hours post 600 mg clopidogrel loading dose
- Informed consent obtained in writing
Exclusion Criteria:
- Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 5.
- Pregnancy
- Breastfeeding
- Inability to give informed consent or high likelihood of being unavailable until Day 5.
- 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 (pseudoaneurysm, arteriovenous shunt, retroperitoneal bleeding or hematoma >5 cm at the arterial catheter insertion site), 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
- 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 on thienopyridine therapy.
- Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
- Thrombocytopenia (<100.000 / μL) at randomization
- Anaemia (Hct <30%) at randomization
- Polycythaemia (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.
- INR>1.5 at randomization
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Prasugrel
Prasugrel 60mg immediate loading dose (Day 0)followed by 10mg/day starting from Day 1 until Day 5
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Prasugrel 60mg immediate loading dose (Day 0)followed by 10mg/day starting from Day 1 until Day 5
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Actieve vergelijker: Clopidogrel
Clopidogrel 150mg/day starting from Day 1 until Day 5
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Clopidogrel 150mg/d starting from Day 1
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Platelet reactivity
Tijdsspanne: 24 hours post randomization (Day 1)
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Platelet Reactivity assessed by VerifyNow P2Y12 assay 24 hours post randomization
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24 hours post randomization (Day 1)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Platelet reactivity
Tijdsspanne: 2 hours post randomization (Day 0)
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Platelet Reactivity assessed by VerifyNow P2Y12 assay 2 hours post randomization
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2 hours post randomization (Day 0)
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Platelet reactivity
Tijdsspanne: 5 days post randomization (Day 5)
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Platelet reactivity assessed by VerifyNow P2Y12 assay 5 days post randomization
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5 days post randomization (Day 5)
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|
Hyporesponsiveness rate
Tijdsspanne: 2 hours post randomization (Day 0)
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Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)2 hours post randomization
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2 hours post randomization (Day 0)
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Hyporesponsiveness rate
Tijdsspanne: 24 hours post randomization (Day 1)
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Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)24 hours post randomization
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24 hours post randomization (Day 1)
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Hyporesponsiveness rate
Tijdsspanne: 5 days post randomization (Day 5)
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Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)5 Days post randomization
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5 days post randomization (Day 5)
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ischemie
- Pathologische processen
- Necrose
- Myocardiale ischemie
- Hartziekten
- Hart-en vaatziekten
- Vaatziekten
- Myocardinfarct
- Infarct
- ST-elevatie myocardinfarct
- Fysiologische effecten van medicijnen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Bloedplaatjesaggregatieremmers
- Purinerge P2Y-receptorantagonisten
- Purinerge P2-receptorantagonisten
- Purinerge antagonisten
- Purinerge middelen
- Clopidogrel
- Prasugrelhydrochloride
Andere studie-ID-nummers
- PATRASCARDIOLOGY-4
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