EUCTR2014-001277-14-GB进行中（未招募）1 期
A Randomised Mechanistic Study Comparing the Effects of Different Anti-platelet Combinations (Ticagrelor vs. Placebo/ Clopidogrel) with Aspirin in Patients presenting with STEMI Treated with Primary PCI - TIMES
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
入选标准
- •For inclusion in the study subjects should fulfill the following criteria:
- •1. Provision of informed verbal consent prior to any study specific procedures taking place with written consent confirmed prior to in-patient cardiac MRI.
- •2. Male or female adult patient aged 18 – 90 years old
- •3. Any STEMI (ST elevation = 2mm in contiguous chest leads) with chest pain symptom onset < 24 hours
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- •1. Cardiogenic shock
- •2. Previous myocardial infarction in the infarct-related artery requiring intervention
- •3. Unfavourable coronary anatomy for PCI: left main/surgical or distal coronary disease
- •4. Already prescribed Ticagrelor at the time of admission
- •5. Factors affecting study drug administration/ absorption: vomiting or allergy to the IMP
- •6. Concomitant use of potent CYP3A4 inhibitors/ inducers (e.g ketoconazole and rifampicin) or CYP3A4 substrates with a narrow therapeutic window (e.g. cisapride and ergot alkaloids) or simvastatin / lovostatin >40mg oral dose.
- •7. Severe bleeding diathesis or current active bleeding
- •8. History of intracranial haemorrhage
- •9. Known Moderate or Severe hepatic impairment or abnormal liver function tests (ALT >5x ULN) at baseline (if available)
- •10. Severe asthma that has required hospital admission or significant bradycardia/ complete heart block diagnosed on ECG (contraindications to
- •adenosine).
- •11. Severe co-morbidity with a life expectancy < 3 months.
- •12. Women of child bearing age unless confirmed by direct questioning that they are reproductively sterile or post-menopausal.
- •13. Concomitant treatment with anticoagulants.
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