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 @ 11:51 AM
Ignite Modification Date:
2025-12-24 @ 11:51 AM
NCT ID:
NCT00448461
Eligibility Criteria:
Inclusion Criteria:
1. Patients older than age 18 to undergo PCI
2. Pretreatment at least 6 hours before PCI with clopidogrel according to the PCI guidelines.
3. Informed, written consent by the patient or her/his legally-authorized representative for participation in the study.
Exclusion Criteria:
1. Recent ST-elevation myocardial infarction within the last 48 hours.
2. Chronic coronary artery occlusion to be treated
3. Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than one year or that may result in protocol non-compliance.
4. Active bleeding, bleeding diathesis, recent surgery (\< 15 days)
5. History of gastrointestinal or genitourinary bleeding within the last 6 weeks
6. Treatment with UFH within 6 hours or low-molecular weight heparin within 8 hours before randomization.
7. Treatment with bivalirudin within 24 hours beforerandomization.
8. Severe uncontrolled hypertension \>180/110 mmHg unresponsive to therapy
9. Relevant hematologic deviations: hemoglobin \< 100 g/L OR platelet count \< 100 x 109 /L.
10. Glomerular filtration rate (GFR) \< 30 ml/min or serum creatinine \> 30 mg/L or dependence on renal dialysis.
11. Known allergy to the study medications: aspirin, clopidogrel, UFH, bivalirudin; stainless steel; true anaphylaxis after prior exposure to contrast media.
12. Known heparin-induced thrombocytopenia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00448461
Study Brief:
Protocol Section:
NCT00448461