Platelet Sub-study of the Neomindset Trial

Korábbi kezelés

• Fibrinolytic therapy < 24 hour before randomization;
• Prior intracranial hemorrhage;
• Impossibility of being treated with dual antiplatelet therapy for 12 months, based on investigator judgement.

Más betegség

• Acute coronary syndrome on index admission treated in a conservative way or by unsuccessful percutaneous intervention or surgically;
• Chronic bleeding diathesis;
• Active or recent major bleeding (in-hospital);
• Index event of non-atherothrombotic etiology (i.e., stent thrombosis, 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;
• Receiver of heart transplant;
• Known allergies or intolerance of acetylsalicylic acid, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin or antiproliferative agents from the limus-family of drugs;
• Any significant medical condition that, in the investigator's opinion, could interfere with the ideal participation of the subject in the study;

Laborértékek

• 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);

Egyéb

• Presence of residual lesions which are likely to require future treatment in the next 12 months;
• Need of oral anticoagulation with warfarin or new anticoagulants;
• Ischemic cerebrovascular accident < 30 days;
• Presence of brain arteriovenous malformation;
• Subject with life expectation lower than 1 year;
• Participation in other study in the past 12 months, unless a direct benefit to the subject can be expected.

• Age >=18 years;
• Clinical presentation compatible with acute coronary syndrome with onset < 24 hours before 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.