Preprocedural Asprin Reload for Native Coronary Disease Treated by Angioplasty: Reperfusion Indexes Evaluation and Improvement of Clinical Outcome -PANTAREI Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluation of pre procedural aspirin overload effect on markers of platelet activation after percutaneous coronary intervention (PCI)
研究概览
简要总结
This is a prospective, randomized study conducted in patients undergoing coronary revascularization procedures (PCI) through angioplasty. All patients who meet the eligibility criteria will be randomized to receive, before the procedure, an oral aspirin reload (325 mg) and to be re-evaluated at 60 minutes, 120 minutes, 6 hours, 48 hours, 5 and 30 day, 3 and 6 months.
详细描述
Study population will be composed of 60 patients with a native coronary chronic occlusion with a vessel diameter equal or superior to 3 mm. The vessels must be treated through a balloon angioplasty and must be completely covered with two stent maximum with a maximum length ≤ 33 mm each. The native coronary chronic occlusion is defined as a native coronary obstruction, if established from at least 30 days, without lumen continuity and a "Thrombolysis In Myocardial Infarction" (TIMI) flow grade equal or superior to 1.
Patient must be treated with an chronic (at least 7 days) oral 100 mg/die aspirin treatment. After the eligibility criteria confirmation, the patient will be randomized with a 1:1 ratio to receive the aspirin reload or not.
Coronary angiographies will be evaluated by the centralized laboratory with the Coronary Quantitative Angiography method.
Myocardial necrosis indexes, ejection fraction, TIMI frame count (TFC) and myocardial blush grade (MBG) variations will represent the short term primary end-points. Clinical events incidence, including death, myocardial infarction, target vessel revascularization and stent thrombosis, will be evaluated at 1, 6 and 12 months.
Study design In every patient will be performed a baseline blood sample collection to evaluate inflammation, platelet activation and oxidative stress indexes. After baseline collection of blood samples, computer-generated random sequence were used for randomization to an oral aspirin reload administration or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •De novo native coronary chronic occlusion with a reference diameter equal or superior to 3 mm programmed treatment;
- •100 mg/die oral aspirin treatment for at least 7 days before the procedure;
- •Target lesion must be covered with two stent maximum with a maximum length ≤ 33 mm each
- •Signed written informed consent
排除标准
- •Aspirin, bisulphate clopidogrel, ticlopidine, heparin, contrast agent or heavy metals known allergy that cannot been medically handled;
- •Target occlusion localized inside a previously implanted graft
- •Target occlusion localized inside a vessel segment previously underwent stent-positioning
- •Target occlusion localized inside a vessel with other occlusion not-to-be treated with the target occlusion same stent(s)
- •Target occlusion localized inside a vessel with other occlusions need to be treated with balloon angioplasty
- •Other techniques than balloon angioplasty target occlusion pre-treatment such as atherectomy, laser intervention or thrombectomy
- •Coronary brachytherapy treated patients
- •Ejection fraction equal or minor to 30%
- •Renal insufficiency (creatinine >3.0 mg/dl)
- •Warfarin-treated patients
- •Life expectancy minor to 12 months
- •Heart transplanted patients
- •Patients still enrolled in some other study, both pharmacological both not
研究组 & 干预措施
Aspirin
All patients who meet the eligibility criteria will be randomized in a 1:1 manner to receive, before the coronary percutaneous procedure, an oral aspirin reload (325 mg)or placebo.
干预措施: Aspirin (Drug)
结局指标
主要结局
Evaluation of pre procedural aspirin overload effect on markers of platelet activation after percutaneous coronary intervention (PCI)
时间窗: Change from baseline at 120 minutes
Changes from the baseline of platelet activation markers (thromboxane) after 60, 120 minutes and 6 hours from the end of percutaneous coronary intervention.
次要结局
- Reperfusion Index(At the end of the procedure (an expected average of 30 minutes))
- Myocardial damage assessed by mean peak values of cardiac troponin I (cTnI) after the percutaneous coronary procedure.(Changes from baseline at 6 hours)
研究者
Francesco Violi
Prof.
University of Roma La Sapienza