ISRCTN18402242已完成2 期
A Phase IIa, randomized, two-arm parallel-group, placebo-controlled, double-blind, multi-centre trial to evaluate the safety, tolerability, anti-inflammatory and cardio-protective effects after intravenous and oral administration of KAND567 in ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention
ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 61 人开始时间: 2021年6月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
研究概览
简要总结
Funder report results in https://kancera.com/en/mfn_news/kancera-reports-positive-top-line-results-from-the-fractal-study/ (added 16/07/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Reperfusion of anterior MI expected within 5 hours of onset of acute chest pain
- •2. Diagnosis of acute myocardial infarction with ST elevation at the J-point in two contiguous leads by ECG (V1-V4 at least two contiguous leads STE 2.0 mm in men and 1.5 mm in women)
- •3. Agreement to undergo routine procedure of PPCI
- •4. Aged =18-75 years
- •5. Willingness and ability to comply with trial procedures, visit schedules, trial restrictions and requirements
- •6. Confirmation of anterior STEMI (TIMI 0-2 flow) by angiography and occlusion of proximal or mid LAD (segments 5 or 6)
- •7. Verbal consent to take part in the trial is given
排除标准
- •1. Anyone with known cognitive impairment or unable to provide verbal consent
- •2. Serious co-existing medical condition, including known hepatic failure and known renal failure with known eGFR <30 ml/min/m² or severe mental disorder, known at the time of randomisation
- •3. Cardiogenic shock, non-compensated acute heart failure and/or pulmonary edema
- •4. Previous known major vascular intervention within the last 4 weeks
- •5. History of previous myocardial infarction (MI) in the LAD
- •6. Documented left ventricular systolic dysfunction (EF <40%)
- •7. Previous coronary artery bypass grafting (CABG)
- •8. Patients unable to tolerate or undergo MRI scanning including patients with claustrophobia, cardiac pacemaker/defibrillator, ferromagnetic metal implants unless approved for use in MRI scanners or excessive body weight
- •9. Known planned hospitalisations (e.g. elective surgery), or other scheduled treatment for pre-existing conditions during the course of the trial that could interfere with clinical assessment
- •10. Known allergy to contrast agent or other contraindications for angiography
- •11. Any known previous diagnosis of invasive cancer within the last 5 years except for treated basal cell carcinoma of the skin
- •12. Current use of steroids or immunosuppressants
- •13. Current use of benzodiazepines
- •14. Current use of ticagrelor (unable to switch to Prasugrel on trial entry)
- •15. Known pre-existing severe liver disease, including chronic hepatitis or alcohol-dependent liver cirrhosis
- •16. Other medical or social reasons for exclusion at the discretion of the investigator
- •17. Administration of any investigational drug within 3 months of trial medication, as far as known to the patient
- •18. Current use of drug sensitive to CYP3A4 inhibition which cannot be paused or switched to an alternative from the same class of medication for the period of IMP administration, including:
- •18.1. Certain P2Y12 inhibitors (clopidogrel)
- •18.2. Certain statins (lovastatin and simvastatin)
- •19. Women of child-bearing potential who are sexually active who are not using a contraceptive method with a failure rate of <1% to prevent pregnancy prior to trial entry. Postmenopausal women must be amenorrhoeic for at least 12 months prior to randomisation to be considered of non-childbearing potential
- •20. Women of child-bearing potential who are not willing to use a contraceptive method with a failure rate of <1% to prevent pregnancy throughout the trial
- •21. Male patients with female partners of childbearing potential not willing to use effective contraception
- •22. Male patients must agree to refrain from donating sperm whilst participating in the trial
研究者
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