- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01575795
Standard (180mg) Versus Double (360mg) Loading Dose of Ticagrelor in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
Standard (180mg) Versus Double (360mg) Loading Dose of Ticagrelor in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI): a Multi-center Randomized Parallel Pharmacodynamic Study.
This is a multi-center, prospective, randomized, single-blind, investigator initiated, pharmacodynamic study of parallel design, performed at 3 institutions (Patras University Hospital; Evangelismos Athens General Hospital; Gennimatas Athens General Hospital).
Patients with ST elevation myocardial infarction (symptom onset < 12 hours), undergoing primary percutaneous coronary intervention, who are antiplatelet naïve (Group A) or present high residual PR (defined as PRU ≥ 208) immediately before primary percutaneous coronary intervention, will be randomized after informed consent, in a 1:1 ratio to either:
Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD )starting 12±6 hours post LD Or Ticagrelor 360mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting 12±6 hours post LD Platelet reactivity assessment will be performed at randomization (Hour 0) and at 0.5, 1, 2, 4 hours after randomization, using the VerifyNow assay, in platelet reactivity units (PRU).
Documentation of major adverse cardiac events (death, myocardial infarction, stroke, urgent revascularization procedure with PCI or CABG) and bleeding (according to Bleeding Academic Research Consortium criteria) will be performed until patient's discharge.
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 4
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Achaia
-
Rio, Achaia, Kreikka, 26500
- Cardiology Department Patras University Hospital
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Age ≥ 18 years old
- Patients with STEMI (onset of pain < 12 hours) with indication for primary PCI
- Antiplatelet naïve or presenting HTPR (≥ 208 PRU) immediately before primary percutaneous coronary intervention
- Informed consent obtained in writing
Exclusion Criteria
- Pregnancy
- Breastfeeding
- Inability to give informed consent or high likelihood of being unavailable until the 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 (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)
- Known hypersensitivity to ticagrelor
- History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months.
- Other bleeding diathesis, or considered by investigator to be at high risk for bleeding
- Any previous history of stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
- Thrombocytopenia (< 100.000/μL) at randomization
- Anaemia (Hct < 30%) at randomization
- Polycytaemia (Hct > 52%) at randomization
- Periprocedural IIb/IIIa inhibitors administration
- Thrombolysis administration
- 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 impairment
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Active Comparator: Ticagrelor 180mg loading dose
|
Ticagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose
Ticagrelor 180mg loading dose 180mg loading dose
|
Kokeellinen: Ticagrelor 360mg loading dose
|
Ticagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose
Ticagrelor 180mg loading dose 180mg loading dose
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms.
Aikaikkuna: 1 hour
|
platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms.
|
1 hour
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms.
Aikaikkuna: 1 hour
|
1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms.
|
1 hour
|
2. Platelet reactivity at 0.5 hour post randomization between the 2 treatment arms separately for Group A and B
Aikaikkuna: 0.5 hour
|
Platelet reactivity at 0.5 hour post randomization between the 2 treatment arms separately for Group A and B
|
0.5 hour
|
Platelet reactivity at 2 hours post randomization between the 2 treatment arms separately for Group A and B
Aikaikkuna: 2 hours
|
Platelet reactivity at 2 hours post randomization between the 2 treatment arms separately for Group A and B
|
2 hours
|
Platelet reactivity at 4 hours post randomization between the 2 treatment arms separately for Group A and B
Aikaikkuna: 4 hours
|
Platelet reactivity at 4 hours post randomization between the 2 treatment arms separately for Group A and B
|
4 hours
|
3. High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 0.5 hour post randomization between the 2 treatment arms, separately for Group A and B
Aikaikkuna: 0.5 hour
|
High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 0.5 hour post randomization between the 2 treatment arms, separately for Group A and B
|
0.5 hour
|
High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 1 hour post randomization between the 2 treatment arms, separately for Group A and B
Aikaikkuna: 1 hour
|
High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 1 hour post randomization between the 2 treatment arms, separately for Group A and B
|
1 hour
|
High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 2 hours post randomization between the 2 treatment arms, separately for Group A and B
Aikaikkuna: 2 hours
|
High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 2 hours post randomization between the 2 treatment arms, separately for Group A and B
|
2 hours
|
High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 4 hours post randomization between the 2 treatment arms, separately for Group A and B
Aikaikkuna: 4 hours
|
High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 4 hours post randomization between the 2 treatment arms, separately for Group A and B
|
4 hours
|
Occurrence of any 5-day bleeding event (BARC Types 1-5)
Aikaikkuna: 5 days
|
Occurrence of any 5-day bleeding event (BARC Types 1-5)
|
5 days
|
Occurrence of 5-day MACEs
Aikaikkuna: 5 days
|
Occurrence of 5-day MACEs
|
5 days
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Dimitrios Alexopoulos, MD, University Hospital of Patras
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Iskemia
- Patologiset prosessit
- Nekroosi
- Sydänlihaksen iskemia
- Sydänsairaudet
- Sydän-ja verisuonitaudit
- Verisuonisairaudet
- Sydäninfarkti
- Infarkti
- ST-korkeus sydäninfarkti
- Huumeiden fysiologiset vaikutukset
- Neurotransmitterit
- Farmakologisen vaikutuksen molekyylimekanismit
- Verihiutaleiden aggregaation estäjät
- Purinergiset P2Y-reseptoriantagonistit
- Purinergiset P2-reseptoriantagonistit
- Purinergiset antagonistit
- Purinergiset aineet
- Ticagrelor
Muut tutkimustunnusnumerot
- PATRASCARDIOLOGY-10
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Ticagrelor
-
AstraZenecaParexelValmis
-
David AntoniucciAstraZeneca; A.R. CARD Onlus FoundationValmisAkuutti sepelvaltimo-oireyhtymä | Haittareaktio verihiutaleiden estoaineelleItalia, Kreikka
-
Bio-innova Co., LtdEi vielä rekrytointia
-
Weill Medical College of Cornell UniversityCanadian Institutes of Health Research (CIHR)Ei vielä rekrytointiaKrooninen sepelvaltimotautiYhdysvallat, Itävalta, Kanada, Saksa, Ruotsi
-
Azienda Ospedaliero Universitaria di SassariAstraZenecaValmisST-korkeus sydäninfarkti | NSTEMI - Ei-ST-segmentin korkeus-MIItalia
-
University of KarachiPharmEvo Private Limited., PakistanValmis
-
University of PatrasValmis
-
Sheffield Teaching Hospitals NHS Foundation TrustAstraZenecaValmis
-
SFJ Pharmaceuticals, Inc.Valmis
-
PhaseBio Pharmaceuticals Inc.Valmis