E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Coronary artery multi-vessel disease and left main stenosis |
Koronararterie fler-karsygdom og venstre hovedstenose |
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E.1.1.1 | Medical condition in easily understood language |
Myocardial infarction or unstable angina. |
Myokardieinfarkt eller ustabil angina. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011098 |
E.1.2 | Term | Coronary bypass |
E.1.2 | System Organ Class | 100000004865 |
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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 |
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to ASA alone improves 12 months outcome defined as major adverse cardiovascular events (MACE) after isolated Coronary Artery Bypass Grafting (CABG) in Acute Coronary Syndrome (ACS) patients. |
At vurdere, om dobbelt blodpladehæmmer behandling med Ticagrelor og Acetylsalicylsyre vs. Acetylsalicylsyre alene kan forbedre resultatet efter isoleret CABG, hos patienter med akutte koronart syndrom.
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E.2.2 | Secondary objectives of the trial |
1. All cause of mortality. 2. Hospitalization with relevant ICD-10 codes obtained from the National Patent Registries. 3. New onset morbidity: A new diagnosis during follow-up, with relevant ICD-10 code in any position, in patients who were free from this diagnosis at baseline (the relevant ICD-10 code never previously recorded in any position). 4. Persistance to treatment assignment (ticagrelor+ASA or ASA alone) obtained from the Dispensed Drug Registry in Sweden. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Written informed consent - Age >=18 years - Has undergone first time isolated CABG due to an episode of acute coronary syndrome (STEMI, NSTEMI, unstable angina) within 6 weeks before surgery |
• Skriftligt informeret samtykke • Alder ≥18 år • Første gangs isoleret CABG på grund af akut koronart syndrom (STEMI, NSTEMI, ustabil angina) inden for 6 uger før operation
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E.4 | Principal exclusion criteria |
• Previously enrolled in this study (i.e. patient now at repeat encounter) • Concomitant surgical procedure other than CABG • Anticoagulant treatment after the operation (e.g. warfarin, direct thrombin inhibitors (dabigatran), FXa inhibitors (rivaroxaban, apixaban, heparin, low-molecular weight heparin, fondaparinux) • Discharge from the operating hospital to an ICU at another hospital • Pregnancy or lactation • Known intolerance or contraindication to ticagrelor or ASA • Any disorder that may interfere with drug absorption • Any condition other than coronary artery disease with a life expectancy <12 months • Known chronic liver disease, renal disease or bleeding disorder • AV-block II and III in patients without pacemaker • Any other indication for dual antiplatelet therapy, i.e. recent stent implantation • Debilitating stroke within 90 days before inclusion • Treatment with immunosuppressants (e.g. cyclosporine and tacrolimus) • Treatment with strong CYP3A4-inhibitors (e.g. ketoconazole, clarithromycin, nefazodon, ritonavir or atazanavir) • Any condition that in the opinion of the investigator may interfere with adherence to trial protocol Participation in any other clinical trial evaluating investigational Products at the time of enrollment in this study
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Tidligere deltaget i denne undersøgelse • Samtidig anden kirurgisk procedure end CABG • Antikoagulerende behandling efter operationen (fx Warfarin, direkte trombininhibitorer (Dabigatran), FXa-hæmmere (Rivaroxaban, Apixaban, Heparin, Heparin med lav molekylvægt, Fondaparinux) • Overflytning fra operationssygehuset til en intensiv afdeling på et andet hospital • Graviditet eller amning • Kendt intolerance eller kontraindikation til Ticagrelor eller ASA • Enhver lidelse, som kan interferere med lægemiddelabsorption • Enhver anden tilstand end kranspulsårers sygdom med en forventet levetid <12 måneder • Kendt kronisk leversygdom, nyresygdom, der kræver dialyse eller blødningsforstyrrelse • AV-blok II og III hos patienter uden pacemaker • Enhver anden indikation for dobbelt blodpladehæmmer behandling, dvs. nylig stentimplantation • Stroke inden for 90 dage før optagelse • Tidligere intrakraniel blødning • Behandling med immunosuppressive midler (fx Cyclosporin og Takrolimus) • Behandling med stærke CYP3A4-hæmmere (fx Ketoconazol, Clarithromycin, Nefazodon, Ritonavir eller Atazanavir) • Enhver betingelse, som efter invistigatorens vurdering kan forstyrre overholdelse af forsøgs protokollen • Deltager på inklusions tidspunktet, i ethvert andet klinisk forsøg, med formålet at evaluere Ticagrelor og/eller Acetylsalicylsyre.
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to all cause death, or myocardial infarction, or stroke, or new revascularization |
Primær: ● Et sammensat effektmål af alle døds årsager, myokardieinfarkt, slagtilfælde eller ny koronarrevaskularisering inden for 12
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
within 12 months. |
12 måneder |
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E.5.2 | Secondary end point(s) |
- Time to all cause death - Time to all cause death, myocardial infarction or stroke - Time to cardiovascular death - Time to first myocardial infarction - Time to first stroke - Time to new revascularization - Time to coronary angiography - Time to hospitalization for heart failure - Time to acute cardiovascular hospitalization - Time to sudden death or aborted cardiac arrest - Time to new-onset AF |
Sekundære: • Tid til alle dødsårsager • Tid til alle dødsfald, myokardieinfarkt eller slagtilfælde • Tid til kardiovaskulær død • Tid til første myokardieinfarkt • Tid til første slagtilfælde • Tid til ny revaskularisering • Tid til koronar angiografi • Tid til indlæggelse af hjertesvigt • Tid til kardiovaskulær indlæggelse • Tid til pludselig død eller afbrudt hjertestop • Tid til ny start AF Primær og sekundære endepunkter vurderes til 1, 12, 24, 36, 60 og 120 måneder.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
12 months and follow up at 2, 3 , 5 and 10 years |
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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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 | Yes |
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 is defined as the last time point for follow up of registry data. This time point occurs approximately 120 months after inclusion of the last patient in the study.
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Afslutning af forsøg er defineret som det sidste tidspunkt, for opfølgning i registreringsdatabasen. Dette tidspunkt opstår ca. 120 måneder efter optagelse af den sidste patient i undersøgelsen |
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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 | 16 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 16 |
E.8.9.2 | In all countries concerned by the trial months | 6 |