EUCTR2012-002314-39-NL进行中（未招募）1 期
Bivalirudin Infusion for Ventricular Infarction Limitation - BIVA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •Patients may be included in the study if they meet all of the following criteria:
- •1.= 18 years
- •2.Experience ischemic symptoms of >20 min and <12 h and have a diagnosis of STEMI with ST segment elevation of =1 mm in =2 contiguous precordial leads, or presumably new left bundle branch block
- •3. Provide written informed consent, or witnessed consent in countries and sites where such patient consenting is applicable, before initiation of any study related procedures
- •4. Have TIMI 0 or 1 flow in the IRA on initial angiogram
- •5. Fulfill angiographic criteria/score for a large infarction based on initial angiogram (APPROACH score of >/=21)
- •6. Are candidates for PPCI
- •7. Administration of an initial dose of 150-325 mg orally (or 250-500 mg IV) and a loading dose of any approved P2Y12 inhibitor
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Patients will be excluded from the study if any of the following exclusion criteria apply prior to enrollment:
- •1. Contraindication or known hypersensitivity to bivalirudin or UFH
- •2. Refusal to receive blood transfusion/products
- •3. Subjects requiring staged coronary artery bypass graft (CABG) procedure within the first 90 days
- •4. Known international normalized ratio (INR) = 2 or known prothrombin time (PT) >1.5 times upper limit of normal on the day of the index PPCI, or known history of bleeding diathesis
- •5. Therapy with vitamin K antagonists (VKA), within 72 h of PPCI
- •6. Therapy with dabigatran, rivaroxaban or other oral anti-Xa or antithrombin agents within 48 h of PPCI
- •7. History of hemorrhagic stroke, intracranial hemorrhage, intracerebral mass, aneurysm, arteriovenous malformation, or recent head injury (within the last 5 days)
- •8. Subjects with previous history of Q-wave MI
- •9. Known glomerular filtration rate (GFR) <30 milliliter (mL)/minute (min) or dialysis dependent
- •10. Major surgery within the previous 30 days
- •11. Minor surgery/biopsy exclusions in the past 3 days
- •12. Upper gastrointestinal or genitourinary bleed 30 days prior to randomisation
- •13. Stroke or transient ischemic attack 30 days prior to randomisation
- •14. Administration of thrombolytics or GPI 72 h prior to PPCI
- •15. Administration of enoxaparin 8 h prior to PPCI
- •16. Administration of bivalirudin 12 h prior to PPCI
- •17. Administration of fondaparinux or other LMWH 24 h prior to PPCI
- •18. Known contraindications to aspirin or P2Y12 inhibitors
- •19. Known allergy that cannot be pre-medicated to iodinated contrast
- •20. Known contraindication to CMR
- •21. Women of child bearing potential (1)
- •22. Previous enrolment in this study
- •23. Treatment with other investigational drugs or devices within the 30 days preceding enrolment or planned use of other investigational drugs or devices before the primary endpoint of this study has been reached
- •24. Patients with a body weight > 150 kg
- •(1) Child bearing potential is defined as:
- •A female patient is considered to have childbearing potential unless she meets at least one of the following criteria:
- •Age =50 years and naturally amenorrhoeic for = 1 year*
- •Premature ovarian failure confirmed by a specialist gynaecologist
- •Previous bilateral salpingo-oophorectomy, or hysterectomy.
- •XY genotype, Turner’s syndrome, uterine agenesis.
- •*Amenorrhoea following cancer therapy does not rule out childbearing potential
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