ETAMI-Study is a clinical trial that tests whether treatment with a new drug (thienopyridine) is able to improve performance and outcome of PCI (i.e. balloon inflation to re-open an occluded vessel in the heart) in patients that suffered myocardial infarction (i.e. acute disease in which one ore more of the blood vessels supplying the heart itself are occluded).
- Conditions
- Myocardial infarction <= 12 hoursMedDRA version: 15.0Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2010-019461-29-DE
- Lead Sponsor
- Stiftung Institut für Herzinfarktforschung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
Age >= 18years and < 75years
Acute STEMI <= 12hrs.
Planned percutaneous coronary intervention
Legal capacity (including ability to understand the nature, scope, and possible consequences of the study participation)
Informed consent
First medical contact in prehospital setting, in a non-PCI hospital, or in a PCI-hospital, if the expected time until the start of the scheduled PCI is at least 20 minutes
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
Age >= 75years
Body weight < 60kg
Thrombolytic therapy within 24hrs before randomization
Oral anticoagulation
Known hemorrhagic diathesis
History of stroke or TIA
Cardiogenic shock
Evidence of active gastrointestinal or urogenital bleeding
Major surgery within 6 weeks
Contraindication to prasugrel or clopidogrel
Severe renal or hepatic insufficiency
Contraindication to coronary angiography
Planned administration of GP IIb/IIIa inhibitor before angiography
Pregnant or nursing women
Patients currently treated with clopidogrel, prasugrel, ticlopidine, or ticagrelor
Uncontrollable hypertension (blood pressure = 200/110 mmHg in repeated measurements)
Treatment with NSAIDs
Participation in another clinical or device trial within previous 30 days
Expected time between administration of loading dose and start of PCI is < 20 minutes
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Inhibition of platelet aggregation by prasugrel and clopidogrel, assessed by the platelet reactivity index (PRI) 2 hrs. after initiation of therapy.;Secondary Objective: PRI 4 hrs. after initiation of therapy<br>Rate of complete ST segement resolution 60min after PCI<br>TIMI 2/3 patency of infarct related artery prior to PCI<br>TIMI 3 patency before PCI<br>TIMI 3 patency after PCI<br>ST resolution before angiography<br>Partial or no ST resolution 60min after PCI<br>ST segment deviation 60min after PCI<br>Death, re-MI, stent thrombosis and urgent revascularisation until 48hrs, day 7, and day 30<br>Stroke<br>Severe bleeding complications;Primary end point(s): Platelet reactivity index measured by VASP phosphorylisation ;Timepoint(s) of evaluation of this end point: 2 hours after the initiation of the therapy
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Platelet reactivity index<br>2) Complete (>70%) ST segment resolution<br>3) TIMI 2/3 patency<br>4) TIMI 3 patency<br>5) TIMI 3 patency<br>6) ST resolution<br>7) Partial or no ST resolution<br>8) ST segment deviation<br>9) Death, re-MI, stent thrombosis, urgent revascularisation;Timepoint(s) of evaluation of this end point: 1) 4 hours after the initiation of the therapy<br>2) 60 minutes after PCI<br>3) prior to PCI<br>4) before PCI<br>5) after PCI<br>6) immediately before angiography<br>7) 60 minutes after PCI<br>8) 60 minutes after PCI<br>9) 48 hours, day 7, day 30<br>