CIPAMI-Study: Clopidogrel administered prehospital to improve primary PCI in Patients with Acute Myocardial Infarction - CIPAMI

Conditions: Myocardial infarction (STEMI) < 6 hrs.
MedDRA version: 8.1Level: LLTClassification code 10000891Term: Acute myocardial infarction

Registration Number: EUCTR2006-000516-24-AT

Lead Sponsor: Stiftung Institut für Herzinfarktforschung

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 654

Inclusion Criteria

Acute STEMI < 6 hrs.
Planned PCI
Age 18 years or older
Ability to understand the nature, scope, and possible consequences of the study / legal capacity
Informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Thrombolytic therapy within 24 hrs.
Effective oral or intravenuous anticoagulation
Hemorrhagic diathesis
Stroke/TIA within 3 months
Active gastrointestinal or urogenital bleeding
Major surgery (including CABG) within 6 weeks
Contraindication to Clopidogrel
Pregnancy/Lactation period
Women with childbearing potential
Treatment with Clopidogrel or Ticlopidine within the last 10 days

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of efficacy, feasibilty, and safety of the administration of a high loading dose clopidogrel in the very early phase of STEMI in the prehospital setting;Secondary Objective: Complications as death, re-MI, urgent revascularisation, stroke, severe bleedings;Primary end point(s): TIMI 2/3 patency of the infarct-related artery immediately prior to PCI

Secondary Outcome Measures