Does Pretreatment With Persantin Reduce Periprocedural Troponin-I Release in Patients Undergoing Elective Single Vessel PCI
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Cardiac troponin-I
研究概览
简要总结
In this study the investigators will investigate whether a short pretreatment (3-7 days) with dipyridamole 200mg twice daily will protect patients against myocardial injury sustained during an elective dotter operation of the coronary arteries (PCI).
The investigators hypothesize that dipyridamole can reduce myocardial injury sustained during elective PCI.
详细描述
Rationale:
In elective PCI (percutaneous coronary intervention) up to 40% of the patients show an asymptomatic rise in myonecrosis marker troponin-I. This release of troponin-I has been found to represent irreversible myocardial injury and has been related to an increased risk of restenosis and even long-term mortality. Dipyridamole has been proven to induce protection against ischemia reperfusion injury and to reduce risk of cardiovascular death or event in secondary prevention after TIA or CVA.
Objective:
To test the hypothesis that dipyridamole improves tolerance to ischemia reperfusion injury in patients undergoing elective PCI.
Study design:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients accepted for elective single, native vessel (left anterior descending, right coronary artery or ramus circumflexus (LAD, RCA or RCX)) PCI in the RUNMC
- •Troponin-I < 0,20 mmol/L at screening
- •Signed Informed consent
排除标准
- •unstable angina
- •recent myocardial infarction (STEMI or non-STEMI), during two weeks prior to inclusion
- •3-Vessel disease as seen on coronary angiogram
- •Stenotic lesion in main stem as seen on coronary angiogram
- •CABG in medical history
- •asthma (recurrent episodes of dyspnoea and wheezing, or usage of prescribed inhalation medication: i.e. corticosteroids or B2-agonists)
- •Treatment with insulin
- •Use of prescribed oral anticoagulants (coumarin derivates)
- •Use of oral corticosteroids
- •Use of sulfonylurea derivates (glibenclamide, tolbutamide, gliclazide, glimepiride)
- •Use of heparin or low molecular weight heparin
- •Use of metformin
- •Use of dipyridamole
- •Chronic use of Non Steroid Anti-Inflammatory Drugs (NSAID's)
研究组 & 干预措施
1
dipyridamole
干预措施: dipyridamole (Drug)
2
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Cardiac troponin-I
时间窗: before and 8 hours after PCI
次要结局
- Effect of PCI on biomarkers reflecting vascular inflammation (hs-CRP, PLA2, PTX3, IL-6, adiponectin, MCP-1, MMP-9)(before and 8 hours after PCI)
- Effect of pretreatment with dipyridamole 2x200mg on biomarkers reflecting vascular inflammation (hs-CRP, PLA2, PTX3, IL-6, adiponectin, MCP-1, MMP-9)(3 days treatment minimal)
研究者
G. Rongen
G. Rongen MD PhD
Radboud University Medical Center