A PHASE III, RANDOMIZED, INTERNATIONAL, MULTICENTER, OPEN LABEL, WITH BLINDED ADJUDICATION OF OUTCOMES, NON-INFERIORITY CLINICAL TRIAL TO EXPLORE THE SAFETY AND EFFICACY OF TICAGRELOR COMPARED WITH CLOPIDOGREL IN PATIENTS WITH ST ELEVATION MYOCARDIAL INFARCTION TREATED WITH PHARMACOLOGICAL THROMBOLYSIS

Associação do Sanatorio Sirio – Hospital do Coração,0 个研究点目标入组 32 人开始时间: 2016年8月16日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•Patients with a diagnosis of acute coronary syndrome with ST elevation with onset during the previous 24 hours, documented by cardiac ischemic symptoms due to atherosclerosis of > 10 minutes duration at rest, treated with pharmacological thrombolysis.
•Both male and female, aged ≥ 18 years and < 75 years
•Agreement to provide written informed consent

•any contraindication against the use of clopidogrel or ticagrelor (eg, hypersensitivity, moderate or severe liver disease, active bleeding or recent bleeding history, history of intracranial hemorrhage)
•need for oral anticoagulation therapy, or aspirin doses per day more than 100mg/day.
•concomitant oral or IV therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3Ainducers (rifampin/rifampicin, phenytoin, carbamazepine)
•Increased risk of bradyarrithmias
•Dialysis required
•Known clinically important thrombocytopenia
•Known clinically important anemia
•Any other condition that may put the patient at risk or influence study results in the investigators´ opinion (eg, cardiogenic shock, severe hemodynamic instability, active cancer)
•Participant in another investigational drug or device study within 30 d
•Current use of Ticagrelor
•Pregnancy or lactation
•Any condition that increases the risk for noncompliance or being lost to follow-up
•Involvement in the planning or conduct of the study
•Previous enrollment or randomization in this study
•Contraindications to fibrinolytic therapy

发起方

Associação do Sanatorio Sirio – Hospital do Coração,