Status:
COMPLETED
Percutaneous Coronary Intervention Followed by Antiplatelet Monotherapy in the Setting of Acute Coronary Syndromes
Lead Sponsor:
Hospital Israelita Albert Einstein
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Based on current scientific evidence, acute coronary syndrome subjects should be treated with dual antiplatelet therapy, which consists of the association of acetylsalicylic acid with an oral antagoni...
Eligibility Criteria
Inclusion
- Subjects must meet all the criteria below:
- Age \>=18 years;
- Acute coronary syndrome with last symptoms \< 24 hours before hospital admission;
- Successful percutaneous coronary intervention(s) of all target lesions (culprit and non-culprit) with new-generation drug-eluting stents;
- Length of stay in hospital at randomization \< 96 hours;
- 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
- Subjects meeting any of the following criteria will be excluded:
- Acute coronary syndrome on index admission treated conservatively or with unsuccessful percutaneous intervention or coronary artery bypass graft;
- Presence of residual lesions which are likely to require future treatment in the next 12 months;
- Fibrinolytic therapy \< 24 hour before randomization;
- Need of oral anticoagulation with warfarin or new anticoagulants;
- Chronic bleeding diathesis;
- Active or recent major bleeding (in-hospital);
- Prior intracranial hemorrhage;
- Ischemic stroke \< 30 days;
- Presence of brain arteriovenous malformation;
- 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);
- Potential or scheduled cardiac or non-cardiac surgery in the next 12 months;
- Platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3;
- Total white blood count \< 3,000 cells/mm3;
- Suspected or documented active liver disease (including laboratory evidence of hepatitis B or C);
- Receiver of heart transplant;
- Known allergies or intolerance to acetylsalicylic acid, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin or antiproliferative agents from the limus-family of drugs;
- Subject with life expectation lower than 1 year;
- Any significant medical condition that, in the investigator's opinion, could interfere with the ideal participation in the study;
- Participation in other study in the past 12 months, unless a direct benefit to the subject can be expected.
- Impossibility of being treated with dual antiplatelet therapy for 12 months, based on investigator judgement.
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
3410 Patients enrolled
Trial Details
Trial ID
NCT04360720
Start Date
October 15 2020
End Date
December 30 2024
Last Update
July 3 2025
Active Locations (50)
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1
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Fortaleza, Ceará, Brazil
2
Instituto Cardiovascular de Linhares
Linhares, Espírito Santo, Brazil
3
Hospital Evangélico de Vila Velha
Vila Velha, Espírito Santo, Brazil
4
Hospital Santa Casa de Misericórdia de Vitória
Vitória, Espírito Santo, Brazil