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 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT01739556
Eligibility Criteria:
Inclusion Criteria:
* 18 years and older, willing consent, undergoing primary PCI for STEMI, within 12 hours of the onset of symptoms, stent implanted successfully, RISK-PCI score for 30-day MACE \>3, alive 24 hours after loading doses, ability to comply with study protocol, negative pregnancy test for women of childbearing potential before enrollment, agree to use a reliable method of birth control during the study
Exclusion Criteria:
* Pre-procedural
* history of hemorrhagic stroke
* ischemic stroke within 30 days of randomization
* evidence of active abnormal bleeding within 3 months of randomization
* high risk for bleeding on long-term antiplatelet therapy
* current therapy with coumadin anticoagulant
* Pregnancy or nursing
* current enrollment in another investigational study Procedural
* balloon angioplasty without stent placement
* unsuccessful PPCI (post-procedural TIMI flow 0) Post-procedural
* active bleeding
* hemoglobin \<10 g/dL or drop in hemoglobin by ≥3 g/dL
* platelet count \<100 000 x 10-9/L.
* TRAP value \<500 aggregation units
* indication for permanent anticoagulant therapy
* need for urgent surgical revascularization
* vascular pseudoaneurysm
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01739556
Study Brief:
Protocol Section:
NCT01739556