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:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT00426751
Eligibility Criteria:
Inclusion Criteria:
* Women must be postmenopausal (i.e.12 months without menstrual period), or surgically sterile, i.e. women of child bearing potential are not allowed to be included into the study. In cases of doubt a pregnancy test should be performed. (NB -post menopausal women currently receiving hormone replacement are permissible)
* Acute myocardial infarction \< 12 h defined as:
1. Angina or equivalent symptoms \> 20 min and
2. ST elevation in 2 contiguous ECG leads (= 2 mm precordial lead, = 1 mm limb lead). This ECG recording serves as baseline ECG, i.e. ECG I.
* Planned primary percutaneous coronary intervention
* The subject has given written informed, dated consent to participate in the study
Exclusion Criteria:
* Subjects not able to give informed consent
* Left Bundle Branch Block
* Thrombolytic therapy within 24 hours before randomization
* Oral anticoagulation with International Normalized Ratio (INR) \> 2
* Known platelets \< 100.000/µl or known hemorrhagic diathesis
* Stroke or Transient Ischemic Attack (TIA) within the past 6 months or any permanent residual neurological defect
* Evidence of an active gastrointestinal or urogenital bleeding
* Major surgery within 6 weeks
* History of allergic reaction to abciximab or eptifibatide or any component used in the study (including contrast media)
* Known severe renal (creatinine clearance \<30ml/min) or hepatic insufficiency as well as Alanine transaminase (ALT)/aspartate transaminase (AST) elevations = 3xUpper limit normal (ULN); isolated AST-elevation is not considered an exclusion criteria from study participation
* Severe concomitant disease with life expectation \< 1 year
* Subject has participated in any study using an investigational drug or device within 30 days or within 5 half-lives of the investigational drug (whichever is longer) of entry into this study.
* Subjects who will be inaccessible due to geographic or social factors during treatment or follow-up
* In France, a subject is neither affiliated with nor a beneficiary of a social security category.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00426751
Study Brief:
Protocol Section:
NCT00426751