Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-25 @ 2:25 AM
NCT ID:
NCT01327534
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years and \< 75 years
* Acute STEMI ≤ 12 h defined as 1. Angina or equivalent symptoms \> 30 min and 2. ST elevation ≥ 2 leads (≥ 2 mm precordial leads, ≥ 1 mm limb leads) or ST depression ≥ 1 mm precordial leads in posterior MI
* planned percutaneous coronary intervention
* legal capacity
* informed consent
* first medical contact in the prehospital setting or in a non-PCI hospital (this criterion was changed by a protocol amendment in autumn 2012 to "first medical contact in the 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")
Exclusion Criteria:
* Age ≥ 75 years
* Body weight \< 60 kg
* Thrombolytic therapy within 24 hours before randomization
* Oral anticoagulation
* Known hemorrhagic diathesis
* History of Stroke or TIA
* Cardiogenic shock
* Evidence of an 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 a GP IIb/IIIa-Inhibitor before angiography
* Pregnant or nursing (lactating) women
* Patients currently (within the last 10 days) 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 the previous 30 days
* First medical contact in a PCI-hospital (this criterion was changed by a protocol amendment in autumn 2012 to "Expected time between administration of loading dose and start of PCI is \< 20 minutes")
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT01327534
Study Brief:
Protocol Section:
NCT01327534