E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Comatose survivors of out-of-hospital cardiac arrest undergoing primary percutaneous coronary intervention |
Komatozni bolniki po izvenbolnišničnem srčnem zastoju in primarni perkutani koronarni intervenciji |
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E.1.1.1 | Medical condition in easily understood language |
Unconscious survivors of out-of-hospital cardiac arrest undergoing cardiac artery stent implantation |
Nezavestni bolniki po izvenbolnišničnem srčnem zastoju in razrešitvi zožitve na venčni arteriji z znotrajžilno opornico |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of the trial is to find out if 4-hour continuous infusion of parenteral P2Y12 inhibitor cangrelor at the start of primary percutaneous coronary intervention immediately and effectively suppresses platelet activity in comatose survivors of out-of-hospital cardiac arrest. Treatment with cangrelor is thereby supposed to bridge the gap of suboptimal platelet inhibition after administration of crushed and dissolved ticagrelor tablets via nasogastric or orogastric tube. |
Namen naše raziskave je preučiti ali štiriurna infuzija intravenskega inhibitorja P2Y12 kangrelorja ob začetku primarne perkutane koronarne intervencije takoj in ustrezno zavre trombocite pri komatonih bolnikih po izvenbolnišničnem srčnem zastoju. Aplikacija kangrelorja naj bi premostila obdobje do zadostnega antiagregacijskega učinka zdrobljenih tablet tikagrelorja, apliciranih po nazogastrični ali orogastrični sondi. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- age 18 to 70 years - comatose survivors of out-of-hospital cardiac arrest undergoing primary percutaneous coronary intervention - treatment with induced therapeutic hypothermia - no contraindication for dual antiplatelet therapy
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- starost 18 do 70 let - komatozni bolniki po izvenbolnišničnem srčnem zastoju z namenom opravljanja primarne perkutane koronarne intervencije - zdravljenje s terapevtsko hipotermijo - brez kontraindikacije za dvojno antiagregacijsko zdravljenje
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E.4 | Principal exclusion criteria |
- pregnancy - patients without return of spontaneous circulation or patients on ECMO - history of recent P2Y12 use (last 7 days) - history of recent vitamin K antagonist or NOAC use (last 14 days) - active bleeding - history of transient ischemic attack or cerebral vascular insult - strong bleeding tendency (Child C liver cirrhosis, stage IV-V chronic renal disease) - history of allergic reactions to acetylsalicylic acid, heparin or P2Y12 inhibitors - terminal disease or life expectancy less than 1 year
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- nosečnice - bolniki brez povrnitve spontanega krvnega obtoka, bolniki na izventelesnem krvnem obtoku - anamneza nedavnega jemanja inhibitorja P2Y12 (v zadnjh 7 dneh) - anamneza nedavnega jemanja antagonistov vitamina K ali novih antikoagulantnih zdravil (v zadnjih 14 dneh) - aktivna krvavitev - anamneza predhodne ishemične možganske kapi ali tranzitornega ishemičnega napada, - pomembna nagnjenost h krvavitvam (jetrna ciroza Child C, kronična ledvična odpoved 4.-5. stopnje) - anamneza alergične reakcije na acetilsalicilno kislino, heparin ali inhibitorje P2Y12 - terminalna bolezen ali pričakovana življenjska doba manj kot 1 leto
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy endpoint: Platelet inhibition measured by VerifyNow and Multiplate 1, 3 and 5 hours after the start of cangrelor infusion Primary safety endpoint: Bleeding (BARC score), need for discontinuation of cangrelor infusion due to significant bleeding |
Primarni cilj učinkovitosti: Inhibicija trombocitov glede na VerifyNow in Multiplate metodo 1, 3 in 5 ur po začetku infuzije kangrelorja Primarni cilj varnosti: Krvavitve (BARC točkovnik), potreba po ukinitvi infuzije kangrelorja zaradi pomembne krvavitve
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the start of the primary percutaneous coronary intervention cangrelor infusion will be started and 1, 3 and 5 hours after initiating the infusion blood samples will be drawn to determine platelet inhibition with VerifyNow and Multiplate methods. Safety profile will be closelly followed until the infusion will be stopped and patients will be monitored in the intensive therapy unit. |
Ob začetku primarne perkutane koronarne intervencije bomo pričeli s kontinuirano infuzijo kangrelorja ter 1, 3 in 5 ure za tem odvzeli kri za določitev zavore trombocitov po metodah VerifyNow in Multiplate. Varnostni profil bomo spremljali ves čas do zaključka infuzije kangrelorja, saj bodo bolniki monitorizirani v sobi intenzivne terapije. |
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E.5.2 | Secondary end point(s) |
Secondary endpoints: Final angiographic result as evaluated by independent blinded interventional cardiologist, probable/definite stent thrombosis during hospital stay, hospital survival, hospital survival with good neurological outcome (CPC 1-2) |
Sekundarni cilji: Končni angiografski rezultat ocenjen s strani neodvisnega interventnega kardiologa, verjetna/gotova stent tromboza med hospitalizacijo, preživetje v bolnišnici, preživetje v bolnišnici z dobrim nevrološkim izhodom (CPC 1-2) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Final angiographic result will be evaluated on the following working day after primary percutaneous coronary intervention. All other secondary endpoints will be evaluated for the time of hospital stay. |
Končni angiografski rezultat bo ocenjen naslednji delovni dan po primarni perkutani koronarni intervenciji. Ostali sekundarni cilji bodo spremljani za čas hospitalizacije. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Established care with ticagrelor crushed and dissolved tablets via nasogastric or orogastric tube |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of trial after 30 enrolled patients (15 test, 15 standard care), block randomization. |
Zaključek raziskave po 30 vključenih bolnikih (15 zdravilo, 15 standardna terapija), "block" randomizacija. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |