Early Thienopyridine Treatment to Improve Primary PCI in Patients With Acute MI

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Acute myocardial infarction is generally caused by a thrombotic occlusion of coronary arteries. Primary aim of early therapy is a fast and complete reperfusion of the infarcted myocardium.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stiftung Institut fuer Herzinfarktforschung
• Collaborators: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Clopidogrel; Prasugrel Hydrochloride; Ticlopidine

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")