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 |
|
E.1.1.1 | Medical condition in easily understood language |
Myocardial infarction or unstable 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 | 10042613 - Surgical and medical procedures |
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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. |
|
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 |
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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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E.5 End points |
E.5.1 | Primary end point(s) |
Time to all cause death, or myocardial infarction, or stroke, or new revascularization |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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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 |
|
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
|
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 12 |
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 | 12 |
E.8.9.2 | In all countries concerned by the trial months | 6 |