PER-089-13已完成未知
A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFECT OF TICAGRELOR 90 MG TWICE DAILY ON THE INCIDENCE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION OR STROKE IN PATIENTS WITH TYPE 2 DIABETES MELLITUS (THEMIS)
ASTRAZENECA - PERU,0 个研究点目标入组 173 人开始时间: 2014年4月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 173
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 50 至 100（—）
- 性别
- All
入选标准
- •1. Provision of informed consent prior to any study specific procedures.
- •2. Men or women ≥50 years of age.
- •3. Diagnosed with T2DM defined by ongoing glucose lowering drug treatment prescribed by a physician for treatment of T2DM since at least 6 months prior to Visit 1.
- •4. At high risk of CV events, defined as history of percutaneous coronary intervention or coronary artery bypass graft or angiographic evidence of ≥ 50% lumen stenosis of at least 1 coronary artery.
排除标准
- •1. Previous Miocardial Infarction.
- •2. Previous stroke.
- •3. Planned use of ADP receptor antagonists and/or use of ASA treatment at doses >150 mg od.
- •4. Planned coronary, cerebrovascular, or peripheral arterial revascularization
- •5. Anticipated concomitant oral or intravenous therapy with strong cytochrome P450
- •3A4 nhibitors or CYP3A4 substrates that cannot be stopped for the course of the study.
- •6. Need for chronic oral anticoagulant therapy or low-molecular-weight heparin.
- •7. Patients with known bleeding diathesis or coagulation disorder, or with uncontrolled hypertension.
- •8. History of previous intracerebral bleed, gastrointestinal bleed within the past 6 months prior to randomisation, or major surgery within 30 days
- •prior to randomisation.
- •9. Increased risk of bradycardic events unless treated with a pacemaker.
- •10. Known severe liver disease.
- •11. Renal failure requiring dialysis.
- •12. Women of child-bearing potential who are not willing to use a accepted method of contraception OR women who have a positive pregnancy test at enrolment OR women who are breast-feeding.
- •13. Inability of the patient to understand and/or comply with study procedures.
- •14. Any condition which in the opinion of the investigator would make it unsafe for the patient to participate in this study.
- •15. Participation in another clinical study with an investigational product within 28 days prior to enrolment.
- •16. Involvement in the planning and/or conduct of the study.
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