EUCTR2016-000880-18-GR进行中（未招募）1 期
A randomized, pharmacodynamic comparison of low dose ticagrelor to clopidogrel in patients with prior myocardial infarction - ALTIC
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Provision of informed consent prior to any study specific procedures
- •2.Post-menopausal female (defined as absence of any vaginal bleeding for a year) or male aged >50 years
- •3.A spontaneous MI (ST or Non ST segment elevation) 1 to 3 years before enrolment. In addition, at least one of the following high-risk features: age of 65 years or older, diabetes mellitus requiring medication, a second prior spontaneous MI, multivessel coronary artery disease, or non-end stage renal disease (estimated creatinine clearance of <60 ml per minute).
- •4.For male participants, receipt of agreement on using effective contraceptive method throughout the duration of their participation in the study (condom ) .
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Planned use of a P2Y12 receptor antagonist, dipyridamole, cilostazol, or anticoagulant therapy during the study period;
- •2.Known allergy, intolerance, hypersensitivity to ticagrelor or clopidogrel or any excipients,
- •3.Active pathological bleeding, severe hepatic impairment, a bleeding disorder or a history of an ischemic stroke or intracranial bleeding, a central nervous system tumor, or an intracranial vascular abnormality;
- •4.Gastrointestinal bleeding within the previous 6 months or major surgery within the previous 30 days;
- •5.Concomitant use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole, grapefruit juice over 1 litre daily), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and rifapentine).
- •6.Increased risk of bradycardic events (e.g. known sick sinus syndrome or third degree AV block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker).
- •7.Inability to adhere to the follow-up requirements or any other reason or condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated.
- •The following restrictions should also be applied to the subjects participating in this study:
- •1. Male subjects should be willing to use barrier methods of contraception during the study and for time period equal to 5 half-lives of the assigned investigational agent after end of study, unless their partners are post-menopausal, surgically sterile or are using accepted contraceptive methods.
- •2. Subjects should not receive treatment during the study with any of the disallowed medications outlined in the Exclusion Criteria (Section 4.2; Exclusion Criteria).
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