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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT00373451
Eligibility Criteria:
Inclusion Criteria:
* Episode of unstable angina
* Elevated cardiac markers
* Angiographic lesions requiring PCI
* Informed, written consent
Exclusion Criteria:
* Age \< 18 years and \> 80 years
* ST-segment elevation acute myocardial infarction within 48 hours
* Cardiogenic shock
* Pericarditis
* Malignancies or other comorbid conditions with life expectancy less than one year or that may result in protocol non-compliance
* Active bleeding; bleeding diathesis; history of gastrointestinal or genitourinary bleeding, recent trauma or major surgery in the last month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection; pericarditis; and patient's refusal to blood transfusion
* Oral anticoagulation therapy with coumarin derivative within the last 7 days
* Recent use of GPIIb/IIIa inhibitors within 14 days
* Treatment with unfractionated heparin within 4 hours unless ACT \> 150sec; or low-molecular weight heparin within 8 hours before randomization
* Treatment with bivalirudin within 24 hours before randomization
* Severe uncontrolled hypertension \> 180/110 mm Hg unresponsive to therapy
* Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days
* Relevant hematologic deviations
* Glomerular filtration rate (GFR) \< 30 ml/min or serum creatinine \> 30 mg/L or dependence on renal dialysis
* Known allergy or intolerance to the study medications, stainless steel or true anaphylaxis after prior exposure to contrast media
* Previous enrollment in this trial
* Women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding
* Patient's inability to fully cooperate with the study protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00373451
Study Brief:
Protocol Section:
NCT00373451