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 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
NCT ID:
NCT02831166
Eligibility Criteria:
Inclusion Criteria:
* ST-segment elevation acute myocardial infarction patients during the first 12 hours of sympton onset;
* Intention to perform primary percutaneous coronary intervention;
* Signed informed consent;
* Patient eligible for transradial and transfemoral primary percutaneous coronary intervention, being pre-requisites: (a) familiarity of the operator with the radial and femoral techniques using vascular closure devices, (b) agreement of the operator to use the access route determined by the randomization process.
Exclusion Criteria:
* Less than 18 years of age;
* Pregnancy;
* Chronic use of vitamin K antagonists or direct thrombin inhibitors, or oral Xa-factor antagonists;
* Hypersensitivity to antiplatelet and/or anticoagulant drugs;
* Active bleeding or high bleeding risk (severe liver failure, active peptic ulcer, creatinine clearance \< 30 mL/min, platelets count \< 100.000 mm3);
* Uncontrolled systemic hypertension;
* Cardiogenic shock;
* Previous myocardial revascularization surgery with ≥ 1 internal mammary or radial artery graft;
* Documented chronic peripheral arterial disease preventing the use of the femoral technique;
* Severe concomitant disease with life expectancy below 12 months;
* Participation in drug or devices investigative clinical trials in the last 30 days;
* Medical, geographic or social conditions impairing the participation in the study or inability to understand and sign the informed consent term.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02831166
Study Brief:
Protocol Section:
NCT02831166