E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
non-ST-segment elevation acute coronary syndrome |
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E.1.1.1 | Medical condition in easily understood language |
non-ST-segment elevation acute coronary syndrome |
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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 primary objectives of this study are to test the following hypotheses: - Completely omitting aspirin is superior to standard DAPT in terms of major or minor bleeding - Completely omitting aspirin is non-inferior to standard DAPT in terms of ischemic events
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to test the following hypotheses: - Completely omitting aspirin does not differ from standard DAPT in terms of net clinical adverse events - Completely omitting aspirin does not differ from standard DAPT in terms of definite or probable stent thrombosis - Completely omitting aspirin does not differ from standard DAPT in terms of repeat revascularization - Completely omitting aspirin is superior to standard DAPT in terms of major or minor bleeding in prespecified subgroups (see Chapter 8.2.1) - Completely omitting aspirin is non-inferior to standard DAPT in terms of ischemic events in prespecified subgroups (see Chapter 8.2.1) - Completely omitting aspirin improves the quality of life compared to standard DAPT - Completely omitting aspirin is costs-effective as compared to standard DAPT
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients aged 18 years or older are eligible for inclusion if all of the following criteria are met: - Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina) - Successful PCI (according to the treating physician)
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E.4 | Principal exclusion criteria |
Patients who meets any of the following criteria will be excluded from participation: - Known allergy or contraindication for aspirin or all commercially available P2Y12-inhibitors (i.e. ticagrelor, prasugrel and clopidogrel) - Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation) - Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS) - Planned surgical intervention within 12 months of PCI - Pregnant or breastfeeding women at time of enrolment - Participation in another trial with an investigational drug or device
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary bleeding endpoint at 12 months is: - Major or minor bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding
The primary ischemic endpoint at 12 months is the composite of: - All-cause mortality - Myocardial infarction (according to the 4th universal definition of MI) - Stroke
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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) |
The secondary endpoints are: - Primary bleeding and ischemic endpoints at 1, 3 and 6 month(s) - Individual components of the primary endpoints at 1, 3, 6 and 12 month(s) - Net adverse clinical events at 1, 3, 6 and 12 month(s) defined as the composite of all-cause mortality, myocardial infarction (according to the 4th universal definition of MI), stroke and major bleeding defined as BARC type 3 or 5 bleeding - Academic Research Consortium (ARC) defined definite or probable stent thrombosis at 1, 3, 6 and 12 month(s) - Repeat revascularization at 1, 3, 6 and 12 month(s) - Periprocedural medication during repeat revascularization - Modifications to aspirin or P2Y12-inhibitor regimen at 1, 3, 6 and 12 month(s)
The cost-effectiveness endpoints are: - Health-related quality of life (QoL) based on the EQ-5D-5L questionnaire at baseline, 1, 3, 6 and 12 month(s) - Resource utilization based on iMTA Medical Consumption Questionnaire (iMCQ) and iMTA Productivity Cost Questionnaire (iPCQ) at 3, 6 and 12 months
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 |
No aspirin vs. aspirin (acetylsalicylic acid) |
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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
| 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 | 15 |
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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Last visit of the last subject |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |