natgillin/translations-raw huggingface dataset:
The incidence of severe or life-threatening bleeding events with eptifibatide was common( > 1/ 100, < 1/ 10); 1.9% vs 1.1% with placebo.
Incidenca hudih ali smrtno nevarnih krvavitev med prejemanjem eptifibatida je bila pogosta (> 1/ 100, < 1/ 10), 1, 9%, med prejemanjem placeba pa 1, 1%.
Eptifibatide treatment increased the need for blood transfusions modestly (11.8% vs 9.3%, placebo).
Zdravljenje z eptifibatidom je nekoliko povečalo potrebo po transfuzijah krvi (11, 8% pri eptifibatidu v primerjavi z 9, 3% pri placebu).
In the subgroup of patients undergoing PCI, major bleeding was observed commonly, in 9.7% of eptifibatide-treated patients vs 4.6% of placebo-treated patients.
V podskupini bolnikov, ki so jim opravili perkutani koronarni poseg, so večje krvavitve ugotavljali pogosteje pri 9, 7% bolnikov zdravljenih z eptifibatidom in pri 4, 6% tistih, ki so prejemali placebo.
Other undesirable effects Overall, in the same trial, serious non-bleeding adverse events were reported at a similar rate in patients treated with eptifibatide and those treated with placebo.
Drugi neželeni učinki Na splošno je bila v zgoraj omenjeni raziskavi pogostnost hudih nehemoragičnih neželenih dogodkov pri bolnikih, zdravljenih z eptifibatidom, podobna tisti pri placebu.
Commonly (> 1/ 100, < 1/ 10) reported events (occurring in ≥ 2% across all groups) in PURSUIT were events related to the underlying disease, such as atrial fibrillation, hypotension, congestive heart failure, cardiac arrest and shock.
Pogosto (> 1/ 100, < 1/ 10) opisani dogodki (ki so se pojavljali pri ≥ 2% bolnikov v vseh skupinah) v raziskavi PURSUIT so bili pojavi, povezani z osnovno boleznijo, npr. atrijska fibrilacija, hipotenzija, kongestivno srčno popuščanje, srčni zastoj in šok.
Adverse events reported within 30 days of initiation of eptifibatide treatment in PURSUIT are reported in Table 1 below.
Neželeni dogodki, opisani v obdobju 30 dni od začetka zdravljenja z eptifibatidom v raziskavi PURSUIT, so podani v tabeli 1.
Patients with unstable angina/ non-Q wave myocardial infarction (NQMI) [PURSUIT trial] received an IV bolus of 180 microgram/ kg followed by continuous infusion of 2.0 microgram/ kg/ min for up to 72 hours (96 hours if PCI performed).
Bolniki z nestabilno angino pektoris ali miokardnim infarktom brez zobca Q v EKG [raziskava PURSUIT] so prejeli intravenski bolus 180 mikrogramov/ kg, ki mu je sledila kontinuirana infuzija 2, 0 mikrograma/ kg/ min v trajanju do 72 ur (96 ur, če je bil narejen perkutani koronarni poseg).
6 Within each frequency grouping in the tables below, undesirable effects are presented in decreasing order of seriousness.
6 V tabelah v nadaljevanju so v razvrstitvah pogostnosti neželeni učinki navedeni po padajoči resnosti.
Reported Adverse Events in PURSUIT at 30 Days* Very common (> 1/ 10), Common (> 1/ 100 ,< 1/10), Uncommon (> 1/ 1,000 ,< 1/100), Rare (> 1/ 10,000, < 1/ 1,000, Very rare (< 1/ 10,000)
Prijavljeni neželeni dogodki do 30 dni po začetku zdravljenja - raziskava PURSUIT * Zelo pogosti (> 1/ 10), Pogosti (> 1/ 100, < 1/ 10), Občasni (> 1/ 1. 000, < 1/ 100), Redki (> 1/ 10. 000, < 1/ 1. 000), Zelo redki (< 1/ 10. 000)
Blood and lymphatic system disorders Very common Major Bleeding
Bolezni krvi in limfatičnega sistema Zelo pogosti
(N=4,696)
(N = 4. 696)
(N=4,679)
(N = 4. 679)
Type or Location of Major Bleeding:
Večje krvavitve
Femoral Artery Access CABG-related Genitourinary Gastrointestinal Retroperitoneal Oral/ Oropharyngeal Haemoglobin/ Haematocrit decrease
femoralni arterijski dostop v povezavi s KPP ** v sečilih in spolnih organih v prebavilih retroperitonealna oralna ali orofaringealna zmanjšanje vrednosti hemoglobina ali hematokrita
Intracranial Very common
intrakranialna
Minor Bleeding
Zelo pogosti
Type or Location of Minor Bleeding:
Vrsta ali mesto manjše krvavitve:
Femoral Artery Access CABG-related Genitourinary Gastrointestinal Oral/ Oropharyngeal Haemoglobin/ Haematocrit decrease Uncommon
femoralni arterijski dostop v povezavi s KPP v sečilih in spolnih organih v prebavilih oralna ali orofaringealna zmanjšanje vrednosti hemoglobina ali hematokrita
Thrombocytopaenia
Trombocitopenija
7 Very common
Zelo pogosti
Any Non-Bleeding Adverse Event
Vsi nehemoragični neželeni dogodki
Cardiac Arrest Ventricular Fibrillation Ventricular Tachycardia Congestive Heart Failure Atrioventricular Block Atrial Fibrillation
Srčni zastoj Ventrikularna fibrilacija Ventrikularna tahikardija Kongestivno srčno popuščanje Atrioventrikularni blok Atrijska fibrilacija
Vascular disorder Common
7 Žilne bolezni Pogosti
Shock Hypotension Phlebitis Nervous system disorders Uncommon
Šok Hipotenzija Flebitis
Cerebral ischaemia
Možganska ishemija
*Causality has not been determined for all adverse events.
* Vzročnost ni bila ugotovljena za vse neželene dogodke. ** KPP - koronarni premostitveni poseg.
Table 2 (below) depicts the incidence of bleeding by TIMI criteria and by invasive cardiac procedures in the PURSUIT trial.
Tabela 2.
Bleeding (TIMI Criteria) by Procedures in the PURSUIT Trial
Krvavitve (po merilih TIMI) po posegih v raziskavi PURSUIT
Major
Večje krvavitve
Minor
Manjše krvavitve
4,577
4. 577
4,604 4,577
4. 604 4. 577
4,604
4. 604
Overall Incidence of Bleeding
Skupna incidenca krvavitev
Breakdown by Procedure:
Razčlenitev po posegih:
CABG Angioplasty without CABG Angiography without angioplasty or CABG
KPP angioplastika brez KPP angiografija brez angioplastike ali KPP
Medical Therapy Only
le medikamentozno zdravljenje
Denominators are based on the total number of patients whose TIMI classification was resolved.
Števci za te odstotke temeljijo na skupnem številu bolnikov, ki so bili razvrščeni po TIMI.
The most common bleeding complications were associated with cardiac invasive procedures (CABG- related or at femoral artery access site).
Najpogostejši hemoragični zapleti so bili povezani z invazivnimi kardialnimi posegi (s koronarno premostitveno operacijo ali na mestu femoralnega arterijskega dostopa).
Major bleeding was infrequent in the PURSUIT trial in the large majority of patients who did not undergo CABG within 30 days of enrollment.
V raziskavi PURSUIT so bile velike krvavitve redke pri veliki večini bolnikov, ki niso imeli koronarnega premostitvenega posega v roku 30 dni po vključitvi v raziskavo.
8 Adverse events reported in the ESPRIT trial are listed in Table 3.
8 Tabela 3 prikazuje prijavljene neželene dogodke v raziskavi ESPRIT.
Reported Adverse Events in ESPRIT * Very common (> 1/ 10), Common (> 1/ 100 ,< 1/10), Uncommon (> 1/ 1,000 ,< 1/100), Rare (> 1/ 10,000, < 1/ 1,000), Very rare (< 1/ 10,000)
Prijavljeni neželeni dogodki v raziskavi ESPRIT * Zelo pogosti (> 1/ 10), Pogosti (> 1/ 100, < 1/ 10), Občasni (> 1/ 1. 000, < 1/ 100), Redki (> 1/ 10. 000, < 1/ 1. 000), Zelo redki (< 1/ 10. 000)
Adverse Event
Neželeni pojav
Blood and lymphatic system disorders Common
Bolezni krvi in limfatičnega sistema Pogosti
(N=1,024)
(N = 1. 024)
(N=1,040)
(N = 1. 040)
Major Bleeding
Večja krvavitev
Type or Location of Major Bleeding:
Vrsta ali mesto večje krvavitve:
Femoral Artery Access Genitourinary Retroperitoneal Intracranial Hematemesis Hematuria Other Common
femoralni arterijski dostop v sečilih in spolnih organih retroperitonealna intrakranialna hematemeza hematurija Drugo
Minor Bleeding
Manjša krvavitev
Femoral Artery Access Gastrointestinal Hematemesis Hematuria Other
femoralni arterijski dostop v prebavilih hematemeza hematurija drugo
Thrombocytopaenia Common
Trombocitopenija
Any Non-Bleeding Adverse Event
Pogosti Vsi nehemoragični neželeni
Cardiac disorders Uncommon
Srčne bolezni Občasni
Cardiac Arrest Ventricular Fibrillation Ventricular Tachycardia Heart Failure Atrioventricular Block Atrial Fibrillation
Srčni zastoj Ventrikularna fibrilacija Ventrilkularna tahikardija Srčno popuščanje Atrioventrikularni blok Atrijska fibrilacija
9 Vascular disorders
Žilne bolezni
Nervous system disorders Uncommon
9 Bolezni živčevja Občasni
*Causality has not been determined for all adverse events.
* Vzročnost ni bila ugotovljena za vse neželene pojave.
Bleeding events were reported at 48 hours and non bleeding events are reported at 30 days.
Krvavitve so prijavljali po 48 urah, nehemoragične neželene pojave pa po 30 dneh.
Blood and lymphatic system disorders Very rare: fatal bleeding (the majority involved central and peripheral nervous system disorders: cerebral or intracranial haemorrhages); pulmonary haemorrhage, acute profound thrombocytopaenia, haematoma, anaemia.
Bolezni krvi in limfatičnega sistema Zelo redke: smrtne krvavitve (večinoma je šlo za motnje osrednjega in perifernega živčevja: možganske ali intrakranialne krvavitve), pljučne krvavitve, akutna huda trombocitopenija, hematomi, slabokrvnost.
Immune system disorders Very rare: anaphylactic reactions.
Bolezni imunskega sistema Zelo redke: anafilaktične reakcije
Skin and subcutaneous tissue disorders Very rare: rash, application site disorders such as urticaria.
Bolezni kože in podkožja Zelo redke: izpuščaj, težave na mestu aplikacije npr. urtikarija
Laboratory values Changes during eptifibatide treatment result from its known pharmacological action, i. e., inhibition of platelet aggregation.
Laboratorijski izvidi Spremembe med zdravljenjem z eptifibatidom nastanejo zaradi njegovega znanega farmakološkega delovanja, t. j. zaviranja agregacije trombocitov.
Thus, changes in laboratory parameters associated with bleeding (e. g., bleeding time) are common and expected.
Zato so spremembe laboratorijskih izvidov v zvezi s strjevanjem krvi (npr. čas krvavitve) pogoste in pričakovane.
No apparent differences were observed between patients treated with eptifibatide or with placebo in values for liver function (SGOT/ AST, SGPT/ ALT, bilirubin, alkaline phosphatase) or renal function (serum creatinine, blood urea nitrogen).
Sicer pa med bolniki, zdravljenimi z eptifibatidom, in tistimi, ki so prejeli placebo, ni bilo očitnih razlik v izvidih delovanja jeter (SGOT/ AST, SGPT/ ALT, bilirubin, alkalna fosfataza) ali ledvic (kreatinin v serumu, dušični retenti iz sečnine v krvi (BUN)).
The experience in humans with overdosage of eptifibatide is extremely limited.
Izkušnje s prevelikim odmerjanjem eptifibatida pri človeku so izredno skope.
There was no indication of severe adverse events associated with administration of accidental large bolus doses, rapid infusion reported as overdose or large cumulative doses.
Pri pomotoma uporabljenih velikih bolusnih odmerkih, hitrih infuzijah, prijavljenih kot preveliko odmerjanje ali pri velikih kumulativnih odmerkih ni bilo znakov hudih neželenih dogodkov.
In the PURSUIT trial, there were 9 patients who received bolus and/ or infusion doses more than double that specified in the protocol, or who were identified by the investigator as having received an overdose.
V raziskavi PURSUIT je bilo 9 bolnikov takih, ki so prejeli bolusni in/ ali infuzijski odmerek, ki je bil več kot dvakrat večji od odmerka, določenega v protokolu, oz. ki so jih raziskovalci označili kot prejemnike prevelikega odmerka.
Antithrombotic agent (platelet aggregation inhibitor excl. heparin), ATC code:
Antitrombotična zdravila (zaviralci agregacije trombocitov z izjemo heparina), ATC oznaka:
10 Eptifibatide, a synthetic cyclic heptapeptide containing six amino acids, including one cysteine amide and one mercaptopropionyl (desamino cysteinyl) residue, is an inhibitor of platelet aggregation and belongs to the class of RGD (arginine-glycine-aspartate)-mimetics.
Eptifibatid, sintetični ciklični heptapeptid s šestimi aminokislinami, vključno z eno cisteinamidno in eno merkaptopropionilno (dezaminocisteinilno) skupino, je zaviralec agregacije trombocitov in sodi v skupino RGD (arginin- glicin- aspartat) - mimetikov.
Eptifibatide reversibly inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor and other adhesive ligands to the glycoprotein (GP)IIb/ IIIa receptors.
Eptifibatid reverzibilno zavira agregacijo trombocitov, saj preprečuje vezavo fibrinogena, von Willebrandovega faktorja in drugih adhezivnih ligandov na receptorje glikoproteina (GP) IIb/ IIIa.
Eptifibatide inhibits platelet aggregation in a dose- and concentration-dependent manner as demonstrated by ex vivo platelet aggregation using adenosine diphosphate (ADP) and other agonists to induce platelet aggregation.
10 Eptifibatid zavira agregacijo trombocitov odvisno od odmerka in koncentracije, kot je pokazala agregacija trombocitov ex vivo z uporabo adenozindifosfata (ADP) in drugih agonistov za indukcijo agregacije trombocitov.
The effect of eptifibatide is observed immediately after administration of a 180 microgram/ kg intravenous bolus.
Učinek eptifibatida je opazen takoj po dajanju intravenskega bolusa 180 mikrogramov/ kg.
When followed by a 2.0 microgram/ kg/ min continuous infusion, this regimen produces a > 80% inhibition of ADP-induced ex vivo platelet aggregation, at physiologic calcium concentrations, in more than 80% of patients.
Če temu sledi trajna infuzija 2, 0 mikrograma/ kg/ min, lahko taka shema pri več kot 80% bolnikov povzroči > 80% zaviranje z ADP- jem inducirane agregacije trombocitov ex vivo pri fiziološki koncentraciji kalcija.
Platelet inhibition was readily reversed, with a return of platelet function towards baseline (> 50% platelet aggregation) 4 hours after stopping a continuous infusion of 2.0 microgram/ kg/ min.
Zaviranje trombocitov je hitro reverzibilno; 4 ure po prekinitvi kontinuirane infuzije 2, 0 mikrograma/ kg/ min se funkcija trombocitov povrne proti izhodiščni vrednosti (> 50% agregacija trombocitov).
Measurements of ADP-induced ex vivo platelet aggregation at physiologic calcium concentrations (D-phenylalanyl-L- prolyl-L-arginine chloromethyl ketone [PPACK] anticoagulant) in patients presenting with unstable angina and Non Q-Wave Myocardial Infarction showed a concentration-dependent inhibition with an IC50 (50% inhibitory concentration) of approximately 550 ng/ ml and an IC80 (80% inhibitory concentration) of approximately 1,100 ng/ ml.
Merjenje z ADP- jem inducirane agregacije trombocitov ex vivo pri fiziološki koncentraciji kalcija (antikoagulant D- fenilalanil- L- prolil- L- arginin klorometilketon [PPACK]) pri bolnikih z nestabilno angino pektoris in miokardnim infarktom brez zobca Q v EKG je pokazalo od koncentracije odvisno zaviranje, z IK50 vrednostjo (50% inhibicijsko koncentracijo) približno 550 nanogramov/ ml in IK80 (80% inhibicijsko koncentracijo) približno 1. 100 nanogramov/ ml.
PURSUIT trial
Raziskava PURSUIT
The pivotal clinical trial for Unstable Angina (UA)/ Non-Q Wave Myocardial Infarction (NQMI) was PURSUIT.
Osrednja klinična raziskava nestabilne angine pektoris ali miokardnega infarkta brez zobca Q v EKG je bila raziskava PURSUIT.
Patients could be enrolled only if they had experienced cardiac ischemia at rest (≥ 10 minutes) within the previous 24 hours and had: • either ST-segment changes:
Potekala je v 726 centrih v 27 državah in je bila dvojno slepa, randomizirana in s placebom kontrolirana raziskava pri 10. 948 bolnikih z nestabilno angino pektoris ali miokardnim infarktom brez zobca Q v EKG.
ST depression > 0.5 mm of less than 30 minutes or persistent ST elevation > 0.5 mm not requiring reperfusion therapy or thrombolytic agents, T-wave inversion (> 1 mm), • or increased CK-MB.
Bolniki so bili lahko v to raziskavo vključeni le, če so imeli v preteklih 24 urah ishemijo miokarda v mirovanju (≥ 10 minut) in: • bodisi spremembe veznice ST: znižanje veznice ST za > 0, 5 mm za manj kot 30 minut ali trdovratno zvišanje veznice ST za > 0, 5 mm, ki ni zahtevalo reperfuzijske terapije ali trombolitičnih zdravil, inverzijo vala T (> 1 mm), • ali povečanje vrednosti CK- MB.
Patients were randomised to either placebo, eptifibatide 180 microgram/ kg bolus followed by a 2.0 microgram/ kg/ min infusion (180/ 2.0), or eptifibatide 180 microgram/ kg bolus followed by a 1.3 microgram/ kg/ min infusion (180/ 1.3).
Bolniki so bili naključno razvrščeni bodisi v skupino za zdravljenje s placebom, skupino za zdravljenje z bolusom eptifibatida 180 mikrogramov/ kg in potem z infuzijo 2, 0 mikrograma/ kg/ min (180/ 2, 0), ali pa v skupino za zdravljenje z bolusom eptifibatida 180 mikrogramov/ kg in potem z infuzijo 1, 3 mikrograma/ kg/ min (180/ 1, 3).
The 180/ 1.3 arm was stopped after an interim analysis, as prespecified in the protocol, when the two active-treatment arms appeared to have a similar incidence of bleeding.
Krak 180/ 1, 3 te raziskave so ustavili po vmesni analizi, kot je bilo vnaprej določeno v protokolu, ker je kazalo, da je incidenca krvavitev v obeh krakih z aktivnim zdravljenjem podobna.
Of the patients in PURSUIT, 13% were managed with PCI during eptifibatide infusion, of whom approximately 50% received intracoronary stents; 87% were managed medically (without PCI during eptifibatide infusion).
87% so jih zdravili konzervativno (brez perkutanega koronarnega posega med infuzijo eptifibatida).
Unfractionated heparin was administered intravenously or subcutaneously at the physician’ s discretion, most commonly as an intravenous bolus of 5,000 U followed by a continuous infusion of 1,000 U/ h.
Nefrakcioniran heparin so jim dajali intravensko ali subkutano po presoji zdravnika, najpogosteje v obliki intravenskega bolusa po 5. 000 enot/ h, ki mu je sledila kontinuirana infuzija po 1. 000 enot/ h.
11 after randomisation, in which case they received intravenous unfractionated heparin to maintain an activated clotting time (ACT) of 300-350 seconds.
V 72 urah po randomizaciji so perkutani koronarni poseg opravili pri skupaj 1. 250 bolnikih, ki so jim v tem primeru intravensko dajali nefrakcioniran heparin, da so aktivirani čas strjevanja (AČS) ves čas ohranjali med 300 in 350 sekundami.
The primary endpoint of the study was the occurrence of death from any cause or new myocardial infarction (MI) (evaluated by a blinded Clinical Events Committee) within 30 days of randomisation.
Primarni končni cilj raziskave je bila smrt iz kakršnegakoli vzroka ali nov miokardni infarkt (MI) (po oceni Komisije za klinične pojave (KKP), ki ni imela podatka o skupini) v roku 30 dni od randomizacije.
The component MI could be defined as asymptomatic with enzymatic elevation of CK-MB or new Q wave.
Miokardni infarkt so opredelili kot asimptomatski pri zvišanju encima CK- MB ali pri pojavu novega zobca Q.
Compared to placebo, eptifibatide administered as 180/ 2.0 significantly reduced the incidence of the primary endpoint events (table 4): this represents around 15 events avoided for 1,000 patients treated:
11 V primerjavi s placebom je eptifibatid uporabljen po shemi 180/ 2, 0 statistično značilno zmanjšal incidenco pojavov primarnega končnega cilja (Tabela 4): to pomeni približno 15 preprečenih pojavov na 1. 000 zdravljenih bolnikov.
Table 4 Incidence of Death/ CEC-Assessed MI (« Treated as Randomised » Population)
MI po oceni KKP (populacija “ zdravljena v skladu z razporeditvijo v skupine ”)
743/ 4,697 (15.8%)
743/ 4. 697 (15, 8%)
667/ 4,680 (14.3%)
667/ 4. 680 (14, 3%)
Pearson’ s chi-square test of difference between placebo and eptifibatide.
Pearsonov test hi- kvadrat za ugotavljanje statistične značilnosti razlike med placebom in eptifibatidom.
According to epidemiological findings, a higher incidence of cardiovascular events has been associated with certain indicators, for instance: − age − elevated heart rate or blood pressure − persistent or recurrent ischemic cardiac pain − marked ECG changes (in particular ST-segment abnormalities) − raised cardiac enzymes or markers (e. g.
Po epidemioloških izsledkih je večja incidenca kardiovaskularnih pojavov povezana z določenimi pokazatelji, npr.:
CK-MB, troponins) and − heart failure
CK- MB, troponini),
ESPRIT trial
Raziskava ESPRIT
ESPRIT (Enhanced Suppression of the Platelet IIb/ IIIa Receptor with eptifibatide Therapy) was a double- blind, randomised, placebo-controlled trial (n= 2,064) for nonurgent PCI with intracoronary stenting.
Raziskava ESPRIT (Enhanced Suppression of the Platelet IIb/ IIIa Receptor with eptifibatide Therapy, t. j. raziskava okrepljenega zaviranja trombocitnih receptorjev IIb/ IIIa z eptifibatidom) je bila dvojno slepa, randomizirana in s placebom kontrolirana raziskava (n = 2. 064) neurgentnega perkutanega koronarnega posega (PCI) z vstavitvijo intrakoronarne opornice.
All patients received routine standard of care and were randomised to either placebo or eptifibatide (2 bolus doses of 180 microgram/ kg and a continuous infusion until discharge from hospital or a maximum of 18-24 hours).
Vsi bolniki so bili deležni rutinske zdravstvene oskrbe in so bili naključno razporejeni bodisi v skupino, ki bo prejemala placebo, ali v skupino, ki bo prejemala eptifibatid (2 bolusna odmerka po 180 mikrogramov/ kg in kontinuirana infuzija do odpusta iz bolnišnice ali največ 18 do 24 ur).
The rate of infusion was 2.0 microgram/ kg/ min for patients with serum creatinine ≤ 175 micromols/ l or 1.0 microgram/ kg/ min for serum creatinine > 175 up to 350 micromols/ l.
Hitrost infuzije pri bolnikih s serumskim kreatininom ≤ 175 mikromolov/ l je bila 2, 0 mikrograma/ kg/ min, pri tistih s serumskim kreatininom > 175 do 350 mikromolov/ l pa 1, 0 mikrogram/ kg/ min.
12 In the eptifibatide arm of the trial, virtually all patients received aspirin (99.7%), and 98.1% received a thienopyridine, (clopidogrel in 95.4% and ticlopidine in 2.7%).
V kraku raziskave z eptifibatidom so praktično vsi bolniki prejeli tudi aspirin (99, 7%), 98, 1% pa jih je prejelo zdravilo iz skupine tienopiridinov (klopidogrel 95, 4% in tiklopidin 2, 7%).
On the day of PCI, prior to catheterization, 53.2% received a thienopyridine (clopidogrel 52.7%; ticlopidine 0.5%) – mostly as a loading dose (300 mg or more).
Na dan perkutanega koronarnega posega je pred katetrizacijo 53, 2% bolnikov prejelo tienopiridin (klopidogrel 52, 7% in tiklopidin 0, 5%), večinoma v obliki udarnega odmerka (300 mg ali več).
The placebo arm was comparable (aspirin 99.7%, clopidogrel 95.9%, ticlopidin 2.6%).
Za placebo krak raziskave je veljalo podobno: aspirin (99, 7%, klopidogrel 95, 9% in tiklopidin 2, 6%).
The ESPRIT trial used a simplified regimen of heparin during PCI that consisted of an initial bolus of 60 units/ kg, with a target ACT of 200 - 300 seconds.
12 V raziskavi ESPRIT so uporabili poenostavljen režim odmerjanja heparina ob perkutanem koronarnem posegu, ki je sestojil iz začetnega bolusa 60 enot/ kg, tarčni AČS pa je bil med 200 in 300 sekund.
The primary endpoint of the trial was death (D), MI, urgent target vessel revascularisation (UTVR), and acute antithrombotic rescue with GP IIb/ IIIa inhibitor therapy (RT) within 48 hours of randomisation.
Primarni končni cilj raziskave je vključeval smrt (D), miokardni infarkt (MI), urgentno revaskularizacijo prizadete žile (UTVR) in akutno antitrombotično terapijo z zaviralcem GP IIb/ IIIa) (RT) v roku 48 ur po randomizaciji.
MI was identified per the CK-MB core laboratory criteria.
Miokardni infarkt so ugotavljali na podlagi osrednjih laboratorijskih meril za CK- MB.
For this diagnosis, within 24 hours after the index PCI procedure, there had to be at least two CK-MB values ≥ 3 x the upper limit of normal; thus, validation by the CEC was not required.
Validacija s strani Komisije za klinične pojave (KKP) tako ni bila potrebna.
The primary endpoint analysis [quadruple composite of death, MI, urgent target vessel revascularisation (UTVR) and thrombolytic bail-out (TBO) at 48 hours] showed a 37% relative and 3.9% absolute reduction in the eptifibatide group (6.6% events versus 10.5%, p = 0.0015).
Analiza primarnega končnega cilja (štirikratni sestavljeni rezultat, opredeljen kot seštevek podatkov za smrt, miokardni infarkt, urgentno revaskularizacijo prizadete žile (UTVR) in trombolitično terapijo (TBO) v prvih 48 urah) je pokazala 37% relativno in 3, 9% absolutno zmanjšanje v skupini za eptifibatid (6, 6% pojavov v primerjavi z 10, 5%, p = 0, 0015).
47 out of 56 MIs in the eptifibitide group).
Rezultate za primarni končni cilj so večinoma pripisali zmanjšanju pojavljanja encimskega miokardnega infarkta, opredeljenega kot zgodnje zvišanje vrednosti srčnih encimov po perkutanem koronarnem posegu (PCI) (80 od 92 miokardnih infarktov v skupini placebo in 47 od 56 miokardnih infarktov v skupini za eptifibatid).