NCT02413268Unknown3 期
Topical Nitroglycerin To Prevent Radial Artery Occlusion After Transradial Access: NTP-RAO Trial
Total Cardiovascular Solutions1 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Radial Artery Occlusion
研究概览
简要总结
A randomized comparison of topical nitroglycerin versus placebo gel for prevention of radial artery occlusion after transradial catheterization.
详细描述
Patients and Methods:
Inclusion criteria:
1: All > 18 years old patients referred for transradial coronary angiography.
Exclusion criteria:
- Absence of informed consent.
- Known allergy to nitroglycerin.
- Ad-hoc PCI
- Previous ipsilateral TRA.
- Warfarin or NOAC therapy.
- Systolic blood pressure < 100 mmHg.
- Critical aortic stenosis (AVA < 0.6 sq.cm)
- Inability to administer unfractionated heparin.
- Need for post-procedural use of heparin (UFH, LMWH)
- Raynaud's disease.
- Sheathless technique or use of > 11 cm sheath.
- History of intractable headache of any cause OR Migraine headache.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for cardiac catheterization.
排除标准
- •1: Absence of informed consent. 2: Known allergy to nitroglycerin. 3: Ad-hoc PCI 4: Previous ipsilateral TRA. 5: Warfarin or NOAC therapy. 6: Systolic blood pressure < 100 mmHg. 7: Critical aortic stenosis (AVA < 0.6 sq.cm) 8: Inability to administer unfractionated heparin. 9: Need for post-procedural use of heparin (UFH, LMWH) 10: Raynaud's disease. 11: Sheathless technique or use of > 11 cm sheath. 12: History of intractable headache of any cause OR Migraine headache.
研究组 & 干预措施
Placebo
Placebo Comparator
Patient receives an antibiotic ointment with no vasoactive drug as a placebo for comparison.
干预措施: Nitroglycerin (Drug)
Nitropaste
Active Comparator
Nitroglycerin 2% ointment is applied above the compression surface on the skin, to evaluate its efficacy in reducing radial artery occlusion.
干预措施: Nitroglycerin (Drug)
结局指标
主要结局
Radial Artery Occlusion
时间窗: up to 2 hours
次要结局
- Headache(up to 4 hours)
- Hypotension(up to 4 hours)
研究者
Dr. Tejas M. Patel, MD
Chairman
Total Cardiovascular Solutions
研究点 (1)
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