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:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT04360720
Eligibility Criteria:
Inclusion Criteria:
Subjects must meet all the criteria below:
1. Age \>=18 years;
2. Acute coronary syndrome with last symptoms \< 24 hours before hospital admission;
3. Successful percutaneous coronary intervention(s) of all target lesions (culprit and non-culprit) with new-generation drug-eluting stents;
4. Length of stay in hospital at randomization \< 96 hours;
5. Subjects will be informed about the nature of the study and must agree to comply and give an informed consent in writing using a form approved in advance by the local Ethics Committee.
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded:
1. Acute coronary syndrome on index admission treated conservatively or with unsuccessful percutaneous intervention or coronary artery bypass graft;
2. Presence of residual lesions which are likely to require future treatment in the next 12 months;
3. Fibrinolytic therapy \< 24 hour before randomization;
4. Need of oral anticoagulation with warfarin or new anticoagulants;
5. Chronic bleeding diathesis;
6. Active or recent major bleeding (in-hospital);
7. Prior intracranial hemorrhage;
8. Ischemic stroke \< 30 days;
9. Presence of brain arteriovenous malformation;
10. Index event of non-atherothrombotic etiology (i.e., stent thrombosis, in-stent restenosis, coronary embolism, spontaneous coronary artery dissection, myocardial ischemia due to supply/demand imbalance);
11. Potential or scheduled cardiac or non-cardiac surgery in the next 12 months;
12. Platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3;
13. Total white blood count \< 3,000 cells/mm3;
14. Suspected or documented active liver disease (including laboratory evidence of hepatitis B or C);
15. Receiver of heart transplant;
16. Known allergies or intolerance to acetylsalicylic acid, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin or antiproliferative agents from the limus-family of drugs;
17. Subject with life expectation lower than 1 year;
18. Any significant medical condition that, in the investigator's opinion, could interfere with the ideal participation in the study;
19. Participation in other study in the past 12 months, unless a direct benefit to the subject can be expected.
20. Impossibility of being treated with dual antiplatelet therapy for 12 months, based on investigator judgement.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04360720
Study Brief:
Protocol Section:
NCT04360720