E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Antiplatelet therapy in patients who undergo coronary artery stenting due to coronary artery disease (CAD) or acute coronary syndrome (ACS). The present study will examine whether ticagrelor, as monotherapy is safe after coronary stenting due to stable CAD and ACS. |
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E.1.1.1 | Medical condition in easily understood language |
Antiplatelet monotherapy in patients who undergo coronary artery stenting due to coronary artery disease (CAD) or acute coronary syndrome (ACS) |
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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 | 22.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048560 |
E.1.2 | Term | Coronary artery disease aggravated |
E.1.2 | System Organ Class | 100000004849 |
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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 | 10071111 |
E.1.2 | Term | Non ST segment elevation acute coronary syndrome |
E.1.2 | System Organ Class | 100000004849 |
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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 |
A pilot study planned to evaluate initial safety of ticagrelor monotherapy after coronary stenting due to acute myocardial infarction. |
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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 |
1. Men or women at least 18 years old. 2. Pre- or intra-procedure treatment with ticagrelor. 3. Coronary stenting with an everolimus-eluting stent (EES) due to NSTEMI or STEMI, with post-procedure diameter stenosis <50% and post-procedure Thrombolysis In Myocardial Infarcton (TIMI) flow grade 3. 4. Subject has not yet received any post-procedure dose of aspirin or any post-procedure dose of a different P2Y12 inhibitor than ticagrelor (loading dose or pre-PCI maintenance dose of aspirin and/or a different P2Y12 inhibitor is allowed) 5. Subject has signed and dated the informed consent form.
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E.4 | Principal exclusion criteria |
1. Planned PCI or any planned surgical intervention within the next 6 months. 2. Any indication for chronic anticoagulant therapy 3. Positive COVID-19 antigen or PCR test regardless of symtoms 4. History of definite stent thrombosis 5. Left main coronary artery stenting. 6. Stent thrombosis/restenosis as a culprit lesion. 7. Visible thrombus on angiography after PCI 8. Usage of glycoprotein IIb/IIIa inhibitors 9. Any bifurcation lesion with stenting of both branches. 10. Any treated lesion within an arterial or venous graft. 11. Any additional lesion(s) that need(s) a staged revascularization. 12. Known ejection fraction < 30%. 13. Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2). 14. Any life-threatening conditions or medical comorbidity resulting in life expectancy < 12 months. 15. Participation in any investigational study that has not yet reached its primary endpoint, and for which monotherapy with ticagrelor may affect the primary outcome (as per the judgement of the investigator). 16. Patients who medicate with a potent CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir) 17. Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception. 18. Expected inability (by the investigator) to comply with the protocol 19. Subjects incapable to giving consent personally |
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E.5 End points |
E.5.1 | Primary end point(s) |
The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis within 3 months. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Within 3 months study start i.e. after the Percutaneous Coronary Intervention (PCI) |
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E.5.2 | Secondary end point(s) |
Time to the following outcomes at 3- and 12 months (unless specified): - Bleeding Academic Research Consortium (BARC) types 3 or 5 bleeding (time-to-event) - Definite or probable stent thrombosis or spontaneous target vessel myocardial infarction (time-to-event) - Any spontaneous myocardial infarction (time-to-event) - All-cause mortality (time-to-event) - The composite of cardiac death, spontaneous target vessel myocardial infarction or definite or probable stent thrombosis within 12 months. - Platelet reactivity as assessed by the ADP-test (multiplate), at 24 hours and 3 months.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At 3- and 12 months (unless specified) |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Feasibility single arm study |
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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 | No |
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.8.5 | 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 | 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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After the 12-month follow-up, the treatment period ends, and the study for this protocol is considered to be over. End of trial is thus defined as the last time point for follow up at 12 months + 30 days. The study will have an acctual period of 12 months and the last patient in the main study will be followed for another 12 months. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |