EUCTR2014-002628-29-GB进行中（未招募）1 期
Evaluating the effectiveness of intravenous ciclosporin on reducing reperfusion injury in patients undergoing primary percutaneous coronary intervention: a double-blind, phase II, randomised controlled trial (CAPRI) - Ciclosporin to reduce reperfusion injury in primary PCI (CAPRI)
ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 52 人开始时间: 2014年8月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
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
- •1. Patients presenting with acute myocardial infarction (STEMI) and undergoing primary percutaneous coronary intervention (primary PCI)
- •2. Age above 18 years
- •3. Presenting within 6 hours of the onset chest pain and ST segment elevation. The culprit coronary artery has to be a major coronary artery with a diameter of at least 3mm and has to be proximally occluded (TIMI flow grade 0-1) at the time of admission coronary angiography
- •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 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 41
排除标准
- •1. Patients with any disorder associated with immunological dysfunction (acute or chronic inflammatory or neoplastic co-existing disease, known positive serology for HIV, or hepatitis)
- •2. Clinically unstable patients (haemodynamically unstable, cardiogenic shock, unconscious patients)
- •3. Patients with evidence of coronary collaterals to the infarct area
- •4. Patients with an open (TIMI > 1) culprit coronary artery at the time of angiography.
- •5. Previous myocardial infarction
- •6. Previous thrombolytic therapy
- •7. Patients with known hypersensitivity to ciclosporin or to egg, peanut or soya-bean proteins.
- •8. Patients with known renal insufficiency (either known GFR <30 ml/min/1.73m2) or current medical care for severe renal insufficiency.
- •9. Known liver insufficiency
- •10. Uncontrolled hypertension (>180/110 mmHg)
- •11. Patients treated with any compound containing hypericum perforatum, stiripentol, Aliskiren, Bosentan or Rosuvastatin or with an active treatment that might modify blood concentration of ciclosporin.
- •12. Female patients currently pregnant or women of childbearing age who are not using contraception (verbal diagnosis). Female patients of childbearing potential who are using contraception but are subsequently found to have a positive urine pregnancy test (pregnancy test performed as soon as reasonably practicable after IMP administration).
- •13. Contraindication to cardiac MRI:
- •- Pacemaker
- •- Implantable defibrillator
- •14. Patients unable to undergo cardiac MRI for any of the following reasons:
- •- Frailty – as judged by the clinician. Frailty is defined as meeting three out of the five following criteria: low grip strength, low energy, slowed walking speed, low physical activity and/or unintentional weight loss. Due to the tight time constraints and emergency setting of this trial the clinician cannot test all these parameters and will need to exercise their judgment.
- •- Claustrophobic - patients who cannot take elevators or who are afraid of narrow or enclosed spaces.
- •- Breathlessness - patients who suffer from breathlessness at rest or low exercise level (e.g. while walking on the level).
- •15. Use of other investigational study drugs within 30 days prior to trial entry (defined as date of randomisation into trial). Co-enrolment with other studies is not allowed.
- •16. Lack of capacity to give initial verbal consent
- •17. Life expectancy <1year due to non-cardiac illness
研究者
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