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Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent thrombosis, myocardial infarction and stroke after coronary stent implantation. Inevitably, it is also associated with a higher risk of (major) bleeding. Given the advances in stent properties, stenting implantation technique and pharmacology, it may be possible to treat patients with a single antiplatelet strategy by completely omitting aspirin.
Objective: This study will assess whether omitting aspirin reduces the rate of major or minor bleeding while remaining non-inferior to the current standard of care with regards to ischemic events in patients with non-ST segment elevation acute coronary syndrome.
Study design: Open-label, multicentre randomized controlled trial.
Study population: Adult patients presenting with non-ST segment elevation acute coronary syndrome undergoing percutaneous coronary intervention.
Intervention: In the intervention group aspirin will be completely omitted from the antiplatelet regimen in the 12 months following PCI.
Main study endpoints: The primary bleeding endpoint is major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding at 12 months. The primary ischemic endpoint is ischemic events defined as the composite of all-cause death, myocardial infarction and stroke at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional arm | Experimental | No aspirin |
|
| Control arm | Active Comparator | Aspirin (75-100 mg once daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No aspirin | Drug | No aspirin |
| |
| Aspirin |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding endpoint | The primary bleeding endpoint at 12 months is major or minor bleeding defined as BARC type 2, 3 or 5 bleeding | 12 months |
| Ischemic endpoint | The primary ischemic endpoint at 12 months is the composite of all-cause mortality, myocardial infarction and stroke | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC, location AMC | Recruiting | Amsterdam | Netherlands |
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| ID | Term |
|---|---|
| C488176 | N-acetyl-S-(alpha-methyl-4-(2-methylpropyl)benzeneacetyl)cysteine 4-(nitrooxy)butyl ester |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Drug |
75-100 mg once daily |
|
| Amsterdam UMC, location VUmc | Recruiting | Amsterdam | Netherlands |
|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |