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The main goal of this clinical trial is to assess whether direct omission of aspirin after Percutaneous Coronary Intervention (PCI) with the continuation of ticagrelor monotherapy for 12 months versus 12 months ticagrelor plus aspirin is equally safe regarding the incidence of ischemic events in patients with ST elevation myocardial infarction (STEMI). Furthermore, the two treatment strategies will be compared regarding the incidence and extent of intramyocardial haemorrhage (IMH) and infarct size in the first week after PCI as determined with Cardiac Magnetic Resonance (CMR). The secondary efficacy endpoint consists of clinical bleeding events and all-cause mortality. The main analyses will comprise of clinical outcomes in the first three months after primary PCI and of CMR results. In addition, we will report on clinical outcomes at thirteen months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Ticagrelor monotherapy instead of dual antiplatelet therapy (aspirin plus ticagrelor) |
|
| Control arm | Active Comparator | Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | Ticagrelor monotherapy for 12 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of major adverse cardiac and cerebral events (MACCE) | Consisting of: myocardial infarction, stent thrombosis, ischemic stroke, cardiovascular mortality / all-cause mortality | 1, 3 and 13 months after primary PCI |
| Intramyocardial haemorrhage (IMH) | Size of IMH and infarct determined by Cardiac Magnetic Resonance imaging at day 5-8 post primary PCI. | day 5-8 post primary PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding complications | Defined as Bleeding Academic Research Consortium (BARC) 2 or greater | 1, 3 and 13 months after primary PCI |
| All-cause mortality | 1, 3 and 13 months after primary PCI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Damman, MD, PhD, FESC | Contact | 0031243616785 | peter.damman@radboudumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noordwest Ziekenhuisgroep Alkmaar | Recruiting | Alkmaar | Netherlands |
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| Aspirin |
| Drug |
Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months |
|
| Platelet reactivity | Differences in platelet reactivity between ticagrelor monotherapy and ticagrelor + aspirin will be measured as Aspirin Reaction Units (ARU) using the VerifyNow test. | 5-8 days |
| Amsterdam UMC | Recruiting | Amsterdam | Netherlands |
|
| Rijnstate | Recruiting | Arnhem | Netherlands |
|
| Medisch Spectrum Twente | Recruiting | Enschede | Netherlands |
|
| Radboudumc | Recruiting | Nijmegen | Netherlands |
|
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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