- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Achaia
-
Rio, Achaia, Grækenland, 26500
- Cardiology Department Patras University Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Prasugrel
Prasugrel 60mg LD followed by 10mg MD starting post 24 hours
|
Prasugrel 60mg LD followed by 10mg x1 MD starting post 24 hours
|
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Platelet reactivity
Tidsramme: 1hour
|
Platelet reactivity Platelet assessed by VerifyNow P2Y12 assay 1 hour post randomization
|
1hour
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Platelet reactivity
Tidsramme: 1 hour
|
Platelet Reactivity assessed by Multiplate analyzer assay 1 hour post randomization
|
1 hour
|
|
Platelet reactivity
Tidsramme: 2 hours
|
Platelet reactivity assessed by the VerifyNow assay 2 hours post randomization
|
2 hours
|
|
Platelet reactivity
Tidsramme: 2 hours
|
Platelet Reactivity assessed by Multiplate analyzer 2 hours post randomization
|
2 hours
|
|
Platelet reactivity
Tidsramme: 6 hours
|
Platelet Reactivity assessed by VerifyNow P2Y12 assay 6 hours post randomization
|
6 hours
|
|
Platelet reactivity
Tidsramme: 6 hours
|
Platelet Reactivity assessed by Multiplate analyzer 6 hours post randomization
|
6 hours
|
|
Platelet reactivity
Tidsramme: 24 hours
|
Platelet Reactivity assessed by VerifyNow P2Y12 assay 24 hours post randomization
|
24 hours
|
|
Platelet reactivity
Tidsramme: 24 hours
|
Platelet Reactivity assessed by Multiplate analyzer 24 hours post randomization
|
24 hours
|
|
Platelet reactivity
Tidsramme: 5 days
|
Platelet Reactivity assessed by VerifyNow P2Y12 assay 5 days post randomization
|
5 days
|
|
Platelet reactivity
Tidsramme: 5 days
|
Platelet Reactivity assessed by Multiplate analyzer 5 days post randomization
|
5 days
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Iskæmi
- Patologiske processer
- Nekrose
- Myokardieiskæmi
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Karsygdomme
- Myokardieinfarkt
- Infarkt
- ST Elevation Myokardieinfarkt
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Blodpladeaggregationshæmmere
- Purinerge P2Y-receptorantagonister
- Purinerge P2-receptorantagonister
- Purinerge antagonister
- Purinerge midler
- Ticagrelor
- Prasugrel Hydrochlorid
Andre undersøgelses-id-numre
- PATRASCARDIOLOGY-8
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Kliniske forsøg med Blodpladereaktivitet
-
Taipei City HospitalAfsluttetPRU (blodpladereaktivitetsenhed) | APT (Antiplatelet Therapy) | HOTPR (High on Treat Platelet Reactivity)Taiwan
Kliniske forsøg med Prasugrel
-
Eli Lilly and CompanyDaiichi Sankyo, Inc.Afsluttet
-
Gyeongsang National University HospitalAfsluttetBlødende | Akut koronarsyndrom | TrombocyttrombeKorea, Republikken
-
University of MilanAfsluttet
-
University of FloridaAfsluttetKoronararteriesygdomForenede Stater
-
University of PatrasAfsluttet
-
Medstar Health Research InstituteAfsluttetAkut koronarsyndromForenede Stater
-
VA Office of Research and DevelopmentAfsluttetKoronararterie bypassForenede Stater
-
Eli Lilly and CompanyAfsluttet
-
Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo CompanyAfsluttetAkut koronarsyndrom (ACS)Taiwan