Acute myocardial infarction
Conditions
Interventions
Trade Name: Acetylsalicylic acid
Product Name: Acetylsalicylic acid
Product Code: Acetylsalicylic acid
Pharmaceutical Form: Tablet
Sponsors
Radboudumc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older are eligible for inclusion if all of the following criteria are met: - Clinical and electrocardiographical diagnosis of ST-elevation myocardial infarction - Successful primary percutaneous coronary intervention (according to the treating physician) of the infarct-related vessel with a modern drug-eluting stent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: - Known allergy or contraindication for aspirin, ticagrelor or prasugrel. - Previous primary percutaneous coronary intervention or acute myocardial infarction less than 12 months ago - Previous cardiac surgery - Participation in another clinical study with an investigational product - Pregnancy and breast feeding - Concurrent use of oral anticoagulants - The periprocedural use of GPIIb/IIIa inhibitors - Planned surgical intervention within 12 months of primary percutaneous coronary intervention - Creatinine clearance <30 mL/min or dialysis - Primary percutaneous coronary intervention of stent thrombosis - Suboptimal stent result as judged by the interventional cardiologist - Contra-indications for cardiac magnetic resonance imaging or unable to undergo cardiac magnetic resonance imaging (only applicable for the cardiac magnetic resonance imaging subgroup population).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical safety of ticagrelor monotherapy directly after primary percutaneous coronary intervention for ST-elevation myocardial infarction with regards to thromboembolic outcomes: (Cardiovascular) death, myocardial infarction, stent thrombosis and ischemic stroke.;Secondary Objective: - To demonstrate the difference in infarct size and intramyocardial haemorrhage measured by cardiac magnetic resonance imaging in favour of ticagrelor monotherapy compared to ticagrelor + aspirin. - To compare (Bleeding Academic Research Consortium) BARC = 2 bleeding outcomes of ticagrelor monotherapy versus dual antiplatelet therapy directly after primary percutaneous coronary intervention for ST-elevation myocardial infarction - To compare all cause mortality in patients receiving ticagrelor monotherapy versus dual antiplatelet therapy. - To compare platelet reactivity between ticagrelor monotherapy and ticagrelor + aspirin. ;Primary end point(s): Composite of major adverse cardiac and cerebral events (MACCE), consisting of: - Myocardial infarction - Stent thrombosis - Ischemic stroke - Mortality (both all-cause mortality and cardiovascular mortality will be taken into account separately. - MACCE including all-cause mortality - Bleeding complications BARC = 2 - All-cause mortality ;Timepoint(s) of evaluation of this end point: 1 month, 3 months and 12 months after primary percutanous coronary intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Size of intramyocardial haemorrhage and infarct determined by cardiac magnetic resonance imaging;Timepoint(s) of evaluation of this end point: Between 5-8 days post primary percutaneous coronary intervention | — |
Countries
Netherlands
Contacts
Public ContactResearch Cardiology Department
Radboudumc
Outcome results
None listed