PercutaNEOus Coronary Intervention Followed by Monotherapy INstead of Dual Antiplatelet Therapy in the SETting of Acute Coronary Syndromes: The NEO-MINDSET Trial

• Status: Recruiting
• Trial end date: 2024-01-30
• Target enrollment: 0
• Participant gender: All

Summary

Phase-3, randomized, multicenter, parallel-group study with blind evaluation of endpoints and intention-to-treat analysis.

The general purpose of the study is evaluate the non-inferiority hypothesis for ischemic events and the superiority hypothesis for bleeding events resulting from platelet P2Y12 receptor inhibitors given as monotherapy in comparison with conventional dual antiplatelet therapy in acute coronary syndrome patients treated with percutaneous coronary intervention in the context of the Unified Health System in Brazil.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Israelita Albert Einstein

Criteria

Inclusion Criteria:

Subjects must meet all the criteria below:

1. Age >=18 years;

2. Clinical presentation compatible with acute coronary syndrome with onset < 24 hours before 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 in a conservative way or by unsuccessful percutaneous intervention or surgically;

2. "Bleeding Risk" assessment not assessible or incomplete;

3. Presence of residual lesions which are likely to require future treatment in the next 12 months;

4. Fibrinolytic therapy < 24 hour before randomization;

5. Need of oral anticoagulation with warfarin or new anticoagulants;

6. Chronic bleeding diathesis;

7. Active or recent major bleeding (in-hospital);

8. Prior intracranial hemorrhage;

9. Ischemic cerebrovascular accident < 30 days;

10. Presence of brain arteriovenous malformation;

11. Index event of non-atherothrombotic etiology (i.e., stent thrombosis, coronary embolism, spontaneous coronary artery dissection, myocardial ischemia due to supply/demand imbalance);

12. Potential or scheduled cardiac or non-cardiac surgery in the next 12 months;

13. Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3;

14. Total white blood count < 3,000 cells/mm3;

15. Suspected or documented active liver disease (including laboratory evidence of hepatitis B or C);

16. Receiver of heart transplant;

17. Known allergies or intolerance of acetylsalicylic acid, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin or antiproliferative agents from the limus-family of drugs;

18. Subject with life expectation lower than 1 year;

19. Any significant medical condition that, in the investigator's opinion, could interfere with the ideal participation of the subject in the study;

20. Participation in other study in the past 12 months, unless a direct benefit to the subject can be expected.

21. Impossibility of being treated with dual antiplatelet therapy for 12 months, based on investigator judgement.