natgillin/translations-raw huggingface dataset:
For all patients, the loading dose could be administered anytime between randomisation and 1 hour after the patient left the catheterisation lab.
Za vse bolnike je bil polnilni odmerek lahko dan kadar koli med randomizacijo in 1 uro po tem, ko je bolnik zapustil kateterizacijski laboratorij.
Date of first authorisation: 16 May 2018
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 16. maj 2018
• Small red bruises on the skin (ecchymoses)
• Majhne rdeče modrice na koži (ekhimoza)
All ACS population
Celotna ACS populacija
Patients should be told that it might take longer than usual to stop bleeding when they take prasugrel (in combination with ASA), and that they should report any unusual bleeding (site or duration) to their physician.
Bolnikom je treba povedati, da bo morda trajalo dlje kot običajno, da se ustavi krvavitev, kadar jemljejo prasugrel (v kombinaciji z ASK), ter da morajo svojemu zdravniku sporočiti vsako neobičajno krvavitev (mesto ali trajanje).
• Sudden numbness or weakness of the arm, leg or face, especially if only on one side of the body
• nenadna odrevenelost ali šibkost rok, nog ali obraza, zlasti če je to samo na eni strani telesa,
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake »EXP«.
The format and means of dissemination, of this material should be discussed with the appropriate learned societies.
Oblika in način razdeljevanja tega gradiva morata biti dogovorjena z ustreznimi strokovnimi združenji.
No (N=13090)
Ne (N = 13090)
Mylan utca 1, Komárom, 2900, Hungary
Mylan utca 1, 2900 Komárom, Madžarska
Children and adolescents Prasugrel Mylan should not be used in children and adolescents below 18 years of age.
Otroci in mladostniki Zdravilo Prasugrel Mylan se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Medicinal products that elevate gastric pH
Zdravila, ki višajo želodčni pH
Subjects with diabetes had significant reductions in the primary and all secondary composite endpoints.
Osebe z diabetesom so imele občutno znižanje primarnih in vseh sekundarnih sestavljenih ciljev študije.
• with body weight <60 kg (see sections 4.2 and 4.8).
• s telesno maso < 60 kg (glejte poglavji 4.2 in 4.8).
You should use Prasugrel Mylan only after discussing with your doctor the potential benefits and any potential risks to your unborn child.
Zdravilo Prasugrel Mylan lahko jemljete samo po posvetu z vašim zdravnikom glede možnih koristi in kakršnih koli možnih tveganjih za vašega nerojenega otroka.
Pharmacokinetic in special populations
Farmakokinetika pri posebnih populacijah
Do not take Prasugrel Mylan if you - are allergic to prasugrel or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Prasugrel Mylan - če ste alergični na prasugrel ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Prasugrel prior to coronary angiographya (N=2037) %
Prasugrel pred koronarno angiografijo (N = 2037) %
It is important that you tell your doctor, dentist and pharmacist, that you are taking Prasugrel Mylan.
Pomembno je, da poveste svojemu zdravniku, zobozdravniku in farmacevtu, da jemljete zdravilo Prasugrel Mylan.
Hazard Ratio (HR) (95% CI)
Razmerje tveganja (RT) (95 % IZ)
You may also have had one or more stents placed to keep open a blocked or narrowed artery supplying blood to the heart.
Morda imate tudi eno ali več žilnih opornic, ki razširjajo zamašeno ali zožano arterijo, ki oskrbuje srce s krvjo.
Inhibitors of CYP3A
Zaviralci CYP3A
Because animal reproduction studies are not always predictive of a human response, Prasugrel Mylan should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.
Ker študije razmnoževanja pri živalih vedno ne napovedo odgovora pri ljudeh, lahko uporabljamo zdravilo Prasugrel Mylan med nosečnostjo samo, če možna korist za mater upraviči možno tveganje za zarodek.
In the All ACS population, analysis of each of the secondary endpoints showed a significant benefit (p<0.001) for prasugrel versus clopidogrel.
V celotni populaciji ACS je analiza vsakega od sekundarnih ciljev kazala pomembno korist (p < 0,001) za prasugrel v primerjavi s klopidogrelom.
- have a medical condition that is currently causing bleeding, such as bleeding from your stomach or intestines.
- če imate zdravstveno stanje, ki trenutno povzroča krvavitev, kot je krvavitev iz želodca ali črevesja.
Bleeding risk
Tveganje za krvavitev
Patients ≥75 years in whom the benefit with prasugrel was more evident included those with diabetes, STEMI, higher risk of stent thrombosis, or recurrent events.
Bolniki ≥ 75 let, pri katerih je bila korist zdravljenja s prasugrelom bolj očitna, so vključevali tiste z diabetesom, s STEMI, večjim tveganjem za trombozo žilne opornice ali ponovljenimi dogodki.
If you take more Prasugrel Mylan than you should Contact your doctor or hospital straight away, as you may be at risk of excessive bleeding.
Če ste vzeli večji odmerek zdravila Prasugrel Mylan, kot bi smeli Nemudoma se obrnite na svojega zdravnika ali bolnišnico, saj imate morda tveganje za prekomerno krvavitev.
A 5 mg maintenance dose should be used.
Uporabiti je treba 5 mg vzdrževalni odmerek.
If you are pregant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Patients ≥75 years old
Bolniki, stari ≥ 75 let
The use of Prasugrel Mylan in patients ≥75 years of age is generally not recommended.
Uporaba zdravila Prasugrel Mylan pri bolnikih, starih ≥ 75 let, na splošno ni priporočena.
You may take Prasugrel Mylan with or without food.
Zdravilo Prasugrel Mylan lahko jemljete s hrano ali brez nje.
You have been prescribed Prasugrel Mylan because you have already had a heart attack or unstable angina and you have been treated with a procedure to open blocked arteries in the heart.
Zdravilo Prasugrel Mylan so vam predpisali, ker ste že imeli srčni infarkt ali nestabilno angino pektoris in so vas zdravili s postopkom, s katerim so odprli zamašene arterije v srcu.
At a very high dose (>240 times the recommended daily human maintenance dose on a mg/m² basis) that caused effects on maternal body weight and/or food consumption, there was a slight decrease in offspring body weight (relative to controls).
Pri zelo visokem odmerku (> 240-kratnik priporočenega dnevnega vzdrževalnega odmerka za ljudi na osnovi mg/m²), ki je povzročil učinke na telesno maso breje samice in/ali uživanje hrane, je bil opazen rahel upad telesne mase mladičev (glede na kontrolo).
Your doctor will also tell you to take acetylsalicylic acid, and (s)he will tell you the exact dose to take (usually between 75 mg and 325 mg daily).
Vaš zdravnik vam bo tudi naročil, da jemljite acetilsalicilno kislino in vam povedal natančen odmerek, ki ga morate vzeti (običajno med 75 mg in 325 mg dnevno).
• Uncontrollable bleeding, for example from a cut
• Nenadzorovana krvavitev, na primer od ureza
• Low haemoglobin or red blood cell count (anaemia)
• Nizek hemoglobin ali nizko število rdečih krvnih celic (anemija)
No dose adjustment is recommended based on ethnicity alone.
Prilagoditev odmerka na osnovi etnične pripadnosti ni potrebna.
Clots in arteries supplying blood to the heart may also reduce the blood supply, causing unstable angina (a severe chest pain).
Strdki v arterijah, ki oskrbujejo srce s krvjo, lahko tudi zmanjšajo dotok krvi, s čimer povzročijo nestabilno angino pektoris (huda bolečina v prsih).
McDermott Laboratories Limited t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange State, Dublin 13, Ireland
McDermott Laboratories Ltd. T/A Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irska
The safety and efficacy of Prasugrel Mylan in children below age 18 has not been established.
Varnost in učinkovitost zdravila Prasugrel Mylan pri otrocih, mlajših od 18 let, nista bili dokazani.
If a patient is to undergo elective surgery, and an antiplatelet effect is not desired, Prasugrel Mylan should be discontinued at least 7 days prior to surgery.
Če ima bolnik predviden nenujen kirurški poseg in če antitrombotični učinek ni zaželen, mora z jemanjem zdravila Prasugrel Mylan prekiniti najmanj 7 dni pred kirurškim posegom.
Approximately 98% of patients (in each of the treatment groups) received antithrombins (heparin, low molecular weight heparin, bivalirudin, or other agent) directly in support of PCI.
Približno 98 % bolnikov (v vsaki skupini zdravljenja) je prejelo antitrombine (heparin, nizko molekularni heparin, bivalirudin ali druga zdravila) neposredno kot podporo PCI.
• with concomitant administration of medicinal products that may increase the risk of bleeding, including oral anticoagulants, clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs), and fibrinolytics.
• s sočasnim dajanjem zdravil, ki lahko povečajo tveganje za krvavitev, vključno s peroralnimi antikoagulanti, klopidogrelom, nesteroidnimi protivnetnimi zdravili (non-steroidal anti inflammatory drugs, NSAID) in fibrinolitiki.
Prasugrel has no or negligible influence on the ability to drive and use machines.
Prasugrel nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin, ATC code: B01AC22.
Farmakoterapevtska skupina: Antitrombotiki, zaviralci agregacije trombocitov brez heparina, oznaka ATC: B01AC22.
The observed benefit of prasugrel in patients ≥75 years was less than that observed in patients <75 years.
Opazovane koristi prasugrela pri bolnikih ≥ 75 let so bile manjše kot pri bolnikih < 75 let.
The tablets should not be crushed or broken.
Tablet ne drobite in ne lomite.
Patients ≥60 kg and age <75 years
Bolniki ≥ 60 kg in < 75 let
More than 98% of subjects had ≥20% inhibition of platelet aggregation during maintenance dosing.
Več kot 98 % oseb je imelo ≥ 20 % zaviranje agregacije trombocitov med vzdrževalnim odmerjanjem.
Tell your doctor if you become pregnant or are trying to become pregnant while you are taking Prasugrel Mylan.
Povejte svojemu zdravniku, če zanosite ali poskušate zanositi, medtem ko jemljete zdravilo Prasugrel Mylan.
Prasugrel showed superior efficacy compared to clopidogrel in reducing the primary composite outcome events as well as the pre-specified secondary outcome events, including stent thrombosis (see Table 3).
Prasugrel je pokazal superiorno učinkovitost v primerjavi s klopidogrelom pri znižanju primarnih sestavljenih izidov kot tudi vnaprej določenih sekundarnih izidov, vključno s trombozo žilne opornice (glejte Preglednico 3).
Inducers of cytochromes P450
Induktorji citokroma P450
Microcrystalline cellulose Mannitol
Mikrokristalna celuloza Manitol
The higher risk for bleeding events in subjects treated with prasugrel persisted up to 7 days from the most recent dose of study drug.
Večje tveganje za krvavitve pri osebah, zdravljenih s prasugrelom, je bilo prisotno še do 7 dni od zadnjega odmerka preiskovanega zdravila.
The benefit was primarily due to a significant decrease in non-fatal MI (see Table 3).
Korist je bila primarno posledica občutnega znižanja ne-smrtnega miokardnega infarkta (glejte Preglednico 3).
• Spontaneous bleeding from the eye, rectum, gums or in the abdomen around the internal organs
• Spontana krvavitev iz očesa, danke, dlesni ali v trebuh okrog notranjih organov
Embryo-foetal developmental toxicology studies in rats and rabbits showed no evidence of malformations due to prasugrel.
Toksikološke študije razvoja ploda/zarodka pri podganah in zajcih niso podale dokazov o malformacijah zaradi prasugrela.
Iron oxide yellow (E172)
Rumeni železov oksid (E172)
Administration of the 60 mg prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 5.2).
Dajanje 60 mg polnilnega odmerka prasugrela na tešče lahko nudi najhitrejši začetek delovanja (glejte poglavje 5.2).
Pharmacokinetics of prasugrel and its inhibition of platelet aggregation are similar in patients with moderate renal impairment (GFR 30<50 ml/min/1.73 m²) and healthy subjects.
Farmakokinetika prasugrela in njegovo zaviranje agregacije trombocitov sta podobna pri bolnikih z zmerno okvaro ledvic (GFR 30 < 50 ml/min/1,73 m²) in zdravih osebah.
Study TADO teste the use of prasugrel (n=171) vs placebo (n=170) in patients, ages 2 to less than 18 years of age, with sickle cell anaemia for reduction of vaso occlusive crisis in a phase III study.
V študiji TADO so proučevali uporabo prasugrela (n = 171) v primerjavi s placebom (n = 170) pri bolnikih, starih od 2 do manj kot 18 let, z anemijo srpastih celic, za zmanjšanje vazookluzivne krize v študiji III. faze.
Therefore, the use of prasugrel in patients at increased risk of bleeding should only be considered when the benefits in terms of prevention of ischaemic events are deemed to outweigh the risk of serious bleedings.
Zato moramo o uporabi prasugrela pri bolnikih s povečanim tveganjem za krvavitev razmisliti, kadar menimo, da koristi v smislu preprečevanja ishemičnih dogodkov pretehtajo tveganje za resne krvavitve.
Other therapies, such as heparin and GP IIb/IIIa inhibitors, were administered at the discretion of the physician.
Druge terapije, kot so heparin in zaviralci GP IIb/IIIa, so bile uporabljene po odločitvi zdravnika.
In a study of healthy subjects, AUC of the active metabolite was unaffected by a high fat, high calorie meal, but Cmax was decreased by 49% and the time to reach Cmax (Tmax) was increased from 0.5 to 1.5 hours.
V študiji pri zdravih osebah je bila AUC aktivnega presnovka nespremenjena pri obroku z veliko maščob in kalorij, vendar se je Cmax znižal za 49 % in čas do dosega Cmax (Tmax) je bil podaljšan z 0,5 na 1,5 ure.
The benefits associated with prasugrel were independent of the use of other acute and long-term cardiovascular therapies, including heparin/low molecular weight heparin, bivalirudin, intravenous GP IIb/IIIa inhibitors, lipid-lowering medicinal products, beta-blockers, and angiotensin converting enzyme inhibitors.
Koristi, povezane s prasugrelom, so bile neodvisne od uporabe drugih akutnih in dolgotrajnih srčno-žilnih terapij, vključno s heparinom/nizko molekularnim heparinom, bivalirudinom, intravenskimi zaviralci GP IIb/IIIa, zdravili za znižanje lipidov, beta-blokatorji in zaviralci encima angiotenzin konvertaze.
• Emphasis that: ◦ Severe haemorrhagic events are more frequent in patients ≥75 years of age (including fatal events) or those weighing <60 kg ◦ Treatment with prasugrel is generally not recommended for patients of ≥75 years of age.
• Poudarek glede: ◦ Hude krvavitve so pogostejše pri bolnikih starih ≥ 75 let (vključno s smrtnimi primeri) ali s telesno maso < 60 kg. ◦ Zdravljenje s prasugrelom na splošno ni priporočeno za bolnike stare ≥ 75 let.
The absorption and metabolism of prasugrel are rapid, with peak plasma concentration (Cmax) of the active metabolite occurring in approximately 30 minutes.
Absorpcija in presnova prasugrela je hitra, vrh plazemske koncentracije (Cmax) aktivnega presnovka se pojavi v približno 30 minutah.
Your doctor should prescribe a daily dose of 5 mg of Prasugrel Mylan if you weigh less than 60 kg - renal (kidney) disease or moderate liver problems - taking certain types of medicines (see ‘Taking other medicines' below) - planned surgery (including some dental procedures) in the next seven days.
Vaš zdravnik vam mora predpisati dnevni odmerek zdravila Prasugrel Mylan 5 mg, če tehtate manj kot 60 kg. - ledvična bolezen ali zmerne težave z jetri, - jemanje nekaterih vrst zdravil (glejte »Jemanje drugih zdravil« spodaj), - načrtovan kirurški poseg (vključno z nekaterimi zobozdravstvenimi posegi) v naslednjih sedmih dneh.
Each bottle contains a desiccant labelled “DO NOT EAT” and 28 or 30 film-coated tablets.
Vsaka plastenka vsebuje sušilno sredstvo z oznako »DO NOT EAT« in 28 ali 30 filmsko obloženih tablet.
In healthy subjects and patients, the pharmacokinetics of prasugrel are similar in men and women.
Spol Pri zdravih osebah in bolnikih je farmakokinetika prasugrela podobna pri moških in ženskah.
The phase 3 TRITON study compared prasugrel with clopidogrel, both co-administered with ASA and other standard therapy.
Faza 3 študije TRITON je primerjala prasugrel s klopidogrelom, oba s sočasnim dajanjem z ASK in drugo standardno terapijo.
If you miss your scheduled daily dose, take Prasugrel Mylan when you remember.
Če ste pozabili vzeti predvideni dnevni odmerek, vzemite zdravilo Prasugrel Mylan, ko se spomnite.
Approximately 40% of patients (in each of the treatment groups) received GP IIb/IIIa inhibitors in support of PCI (no information available regarding the type of GP IIb/IIIa inhibitor used).
Približno 40 % bolnikov (v vsaki skupini zdravljenja) je prejelo zaviralce GP IIb/IIIa, kot podporo PCI (podatkov o uporabljenem tipu zaviralca GP IIb/IIIa ni na voljo).
You should tell your doctor before taking Prasugrel Mylan if any of the situations mentioned below apply to you:
Povejte svojemu zdravniku, preden vzamete zdravilo Prasugrel Mylan, če se katero koli izmed spodnjih stanj nanaša na vas:
Prasugrel was associated with a 50% reduction in stent thrombosis through the 15 month follow-up period.
Prasugrel je bil povezan s 50 % zmanjšanjem tromboze žilne opornice v 15-mesečnem obdobju spremljanja.
This effect is likely to be of clinical concern only when prasugrel is co administered with medicinal products for which CYP2B6 is the only metabolic pathway and have a narrow therapeutic window (e.g. cyclophosphamide, efavirenz).
Ta učinek je klinično pomemben samo, kadar prasugrel dajemo sočasno z zdravili, za katere je edina pot presnove CYP2B6 in imajo ozko terapevtsko širino (npr. ciklofosfamid, efavirenz).
In the large phase 3 clinical trial, the mean estimated exposure (AUC) of the active metabolite was 19% higher in very elderly patients (≥75 years of age) compared to subjects <75 years of age.
V velikem kliničnem preskušanju faze 3 je bila srednja ocenjena izpostavljenost (AUC) aktivnemu presnovku 19 % višja pri zelo starih bolnikih (≥ 75 let) v primerjavi z osebami < 75 let.
In the All ACS population, prasugrel was associated with a lower incidence of CV death, non-fatal MI, or non-fatal stroke compared to clopidogrel, regardless of baseline characteristics such as age, sex, body weight, geographical region, use of GP IIb/IIIa inhibitors, and stent type.
V celotni ACS populaciji je bil prasugrel povezan z nižjo incidenco srčnožilne smrti, ne-smrtnega miokardnega infarkta ali ne-smrtne možganske kapi v primerjavi s klopidogrelom, neodvisno od osnovnih značilnosti, kot so starost, spol, telesna masa, geografsko področje, uporaba zaviralcev GP IIb/IIIa in tip žilne opornice.
All of the above may be signs of bleeding, the most common side effect with Prasugrel Mylan.
Vse zgoraj našteto so lahko znaki krvavitve, najpogostejšega neželenega učinka z zdravilom Prasugrel Mylan.
Of these, bleeding was the most common adverse reaction for both drugs leading to study drug discontinuation (2.5% for prasugrel and 1.4% for clopidogrel).
Od teh je bil pri obeh zdravilih najpogostejši neželeni učinek krvavitev, ki je vodila v prekinitev jemanja preiskovanega zdravila (2,5 % za prasugrel in 1,4 % za klopidogrel).
If given together with Prasugrel Mylan these medicines may increase the risk of bleeding.
Če jih jemljete skupaj z zdravilom Prasugrel Mylan, lahko ta zdravila povečajo tveganje za krvavitev.
Patients <60 kg
Bolniki, ki tehtajo < 60 kg
Patients with STEMI within 12 hours of symptoms and planned for primary PCI could be randomised without knowledge of coronary anatomy.
Bolniki s STEMI v 12 urah simptomov in načrtovano primarno PCI so lahko bili randomizirani brez ugotovljene srčne anatomije.
The use of Prasugrel Mylan in patients ≥75 years of age is generally not recommended and should only be undertaken with caution after a careful individual benefit/risk evaluation by the prescribing physician indicates that benefits in terms of prevention of ischaemic events outweigh the risk of serious bleedings.
Uporaba zdravila Prasugrel Mylan pri bolnikih ≥ 75 let starosti na splošno ni priporočena in mora biti opravljena previdno, samo po skrbni oceni lečečega zdravnika glede posameznikove koristi/tveganja, ki meni, da koristi v smislu preprečevanja ishemičnih dogodkov pretehtajo tveganje za resne krvavitve.
A treatment of up to 12 months is recommended unless the discontinuation of Prasugrel Mylan is clinically indicated (see sections 4.4 and 5.1).
Priporoča se zdravljenje do 12 mesecev, razen če je prekinitev zdravljenja z zdravilom Prasugrel Mylan klinično indicirana (glejte poglavji 4.4 in 5.1).
Table 2 summarises haemorrhagic and non-haemorrhagic adverse reactions in TRITON, or that were spontaneously reported, classified by frequency and system organ class.
Preglednica 2 vključuje hemoragične in ne-hemoragične neželene učinke v študiji TRITON ali tiste, o katerih so poročali spontano, razvrščene po pogostnosti in organskih sistemih.
The MAH should provide educational material to all physicians who may be involved in treating patients with prasugrel.
Imetnik dovoljenja za promet z zdravilom mora vsem zdravnikom, ki bi lahko bili vključeni v zdravljenje bolnikov s prasugrelom, zagotoviti izobraževalno gradivo.
For patients with active bleeding for whom reversal of the pharmacological effects of prasugrel is required, platelet transfusion may be appropriate.
Za bolnike z aktivno krvavitvijo, za katere je potrebno izničenje farmakoloških učinkov prasugrela je lahko primerna transfuzija trombocitov.
There was an increased incidence of tumours (hepatocellular adenomas) in mice exposed for 2 years to high doses (>75 times human exposure), but this was considered secondary to prasugrel-induced enzyme-induction.
Povečana incidenca tumorjev (hepatocelularni adenomi) je bila opazna pri miših, ki so bile 2 leti izpostavljene visokim odmerkom (> 75-kratni odmerek v primerjavi z ljudmi), vendar so to ocenili kot sekundarno glede na indukcijo encima, povzročeno s prasugrelom.
What Prasugrel Mylan is and what it is used for What you need to know before you take Prasugrel Mylan How to take Prasugrel Mylan Possible side effects
Kaj je zdravilo Prasugrel Mylan in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Prasugrel Mylan Kako jemati zdravilo Prasugrel Mylan Možni neželeni učinki
You should show the doctor your pack of Prasugrel Mylan.
Zdravniku morate pokazati vašo škatlo zdravila Prasugrel Mylan.
If clots form within a hardened blood vessel such as an artery they can be very dangerous as they can cut off the blood supply, causing a heart attack (myocardial infarction), stroke or death.
Če se strdki tvorijo v trdi žili, kot je arterija, so lahko zelo nevarni, ker lahko prekinejo dotok krvi, s čimer povzročijo srčni infarkt (miokardni infarkt), možgansko kap ali smrt.
These included definite or probable stent thrombosis at study end (0.9% vs 1.8%; HR 0.498; CI 0.364, 0.683); CV death, nonfatal MI, or urgent target vessel revascularisation through 30 days (5.9% vs 7.4%; HR 0.784; CI 0.688,0.894); all cause death, nonfatal MI, or nonfatal stroke through study end (10.2% vs 12.1%; HR 0.831; CI 0.751, 0.919); CV death, non-fatal MI, nonfatal stroke or rehospitalisation for cardiac ischaemic event through study end (11.7% vs 13.8%; HR 0.838; CI 0.762, 0.921).
Te so vključevale določene ali možne tromboze žilne opornice ob koncu študije (0,9 % proti 1,8 %; RT 0,498; IZ 0,364; 0,683); srčno-žilno smrt, nesmrtni miokardni infarkt ali urgentno ciljno žilno revaskulizacijo v 30 dneh (5,9 % proti 7,4 %; RT 0,784; IZ 0,688; 0,894); vse vzroke smrti, ne-smrtni miokardni infarkt ali ne-smrtno možgansko kap do konca študije (10,2 % proti 12,1 %; RT 0,831; IZ 0,751; 0,919); srčno-žilno smrt, ne-smrtni miokardni infarkt, ne-smrtno možgansko kap ali ponovno hospitalizacijo zaradi srčnega ishemičnega dogodka do konca študije (11,7 % proti 13,8 %; RT 0,838; IZ 0,762; 0,921).