Rationale and Design of the OCEAN Study (Long-term mOno-antiplatelet Drug Strategy After perCutanEous coronAry interveNtion), A Multicenter, Prospective, Registered Branch of the RESCIND Study
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 7
- 主要终点
- Antiplatelet-induced Gastrointestinal Injury Symptom(AI-GIS)
研究概览
简要总结
The OCEAN (long-term mOn-antiplatelet drug strategy after perCutanEous coronANy intervention) study is the largest prospective multicenter data base to investigate the long-term incidence and prognosis of the use of agents for antiplatelet-induced GI injury symptoms (AI-GIS) or GI hemorrhage among patients undergoing PCI. The OCEAN study will provide evidence of the long-term incidence and prognosis of use of agents for AI-GIS among patients undergoing PCI. It has the potential to provide an optimal long-term mono-antiplatelet strategy.
详细描述
This is a multicenter prospective observational study that will collect data on >1000 alive patients who have undergone PCI between 1 and 1.5 years prior at 9 hospitals from October 2018. Adult patients (aged ≥18 years) undergoing PCI and prescribed mono-antiplatelet agents (such as aspirin, dihydroxyaluminum aminoacetate-heavy magnesium carbonate-aspirin, and clopidogrel) are eligible for enrollment. In phase 1, patients will be investigated in a cross-sectional manner for the withdrawal rate of dual antiplatelet agents within 1 year after stent implantation. In phase 2, patients will be followed up at 1, 3, and 6 months for AI-GIS and other outcomes. The primary endpoint is AI-GIS (according to the Gastrointestinal Symptom Rating Scale score) or gastrointestinal hemorrhage. Secondary outcomes will include bleeding, antiplatelet replacement/discontinuation, health economic cost, utilization ratio of gastrointestinal-protective drugs, and MACE.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years
- •Currently alive at 1-1.5 years after PCI
- •Considered by the physician to be suitable for long-term treatment with mono-antiplatelet agents and is currently using a mono-antiplatelet drug (aspirin, clopidogrel, or dihydroxyaluminum aminoacetate-heavy magnesium carbonate-aspirin [ASIDE])
- •Provided written informed consent for this study.
排除标准
- •Refusal to sign the informed consent form
- •Acute coronary syndromes
- •Cerebral thrombosis within 1 month or cerebral hemorrhage within 1 year
- •Hematopathy or non-GI bleeding tendency
- •Allergy to aspirin
- •Severe uncontrolled hypertension (>180/110 mmHg)
- •Pregnancy or lactation
- •Drug or alcohol abuse
- •Malignant tumor or <1-year life expectancy
结局指标
主要结局
Antiplatelet-induced Gastrointestinal Injury Symptom(AI-GIS)
时间窗: 1 year after PCI
AI-GIS was estimated according to the Gastrointestinal Symptom Rating Scale(GSRS). This scale included a total of 15 evaluation indicators(Abdominal pains、Heartburn、Acid regurgitation、Sucking sensations in the epigastrium、Nausea and vomiting、Borborygmus、Abdominal distension、Eructation、Increased flatus、Decreased passage of stools、Increased passage of stools、Loose stools、Hard Stools、Urgent need for defecation、Feeling of incomplete evacuation）. The score for each indicator was determined by intensity, frequency, duration, request for relief, and impact on social performance. A score of 0 indicated no or only transient symptoms. A score of 3 indicated continuous discomfort with impact on all social activities. The total minimum score was 0 points and the total maximum score was 45 points. Higher score represented a worse outcome.
次要结局
- Health Economic Costs(1-1.5 years after PCI)
- Utilization Rate of GI Protection Drug(1-1.5 years after PCI)
- Conversion of Antiplatelet Drug(1-1.5 years after PCI)
- Discontinuation of Antiplatelet Drug(1-1.5 years after PCI)
- Major Adverse Cardiovascular Events(1-1.5 years after PCI)
- Bleeding Events(1-1.5 years after PCI)
研究者
Liu yong
MD, PhD
Guangdong Provincial People's Hospital