Cardiovascular Risk Reduction in Atrial Fibrillation Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,675
- 试验地点
- 1
- 主要终点
- Hierarchical composite cardiovascular outcomes
研究概览
简要总结
Atrial fibrillation (AF) is a serious public health problem because of its increasing incidence and prevalence in the aging population. AF is associated with elevated risks of death, stroke, coronary event, heart failure, cognitive decline, and chronic kidney disease. To identify preventive interventions for major cardiovascular events beyond effective anticoagulation should be a major priority in the treatment of AF patients. The CRAFT study is a 2-arm, multicenter, randomized clinical trial designed to test whether intensive blood pressure control will reduce the risk of major cardiovascular events in AF patients.
详细描述
The CRAFT trial will include approximately 1675 AF patients with home SBP 125-154 mmHg and at least another cardiovascular risk factor. The trial aims to compare the effects of randomization to a treatment program of an intensive SBP goal (target home SBP <120mmHg) with randomization to a treatment program of a standard goal (target home SBP <135mmHg). The primary hypothesis is that cardiovascular event rates will be lower in the intensive arm. Participants will be recruited over a 4-year period at approximately 100 to 150 clinical centres and the first patient will be followed for up to 5 years.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intensive BP Control
Participants randomized into the Intensive BP Control arm will have a goal of home SBP <120mmHg. For most participants in the Intensive Group, a two- or three-drug regimen should be initiated at randomization. Following the randomization visit, addition of another drug or medication dose titration is indicated if home SBP is ≥120 mmHg. Monthly visits will continue in the Intensive Group until home SBP <120 mmHg or no more titration planned. If the home SBP is not <120 mmHg at the every 6-month visit, then an antihypertensive drug from a class different from what is being taken should be added, rather than up-titration the dosage of previous drugs, unless there are compelling reasons against this practice.
干预措施: Intensive BP Control (Drug)
Standard BP Control
Participants randomized into the Standard BP Control arm will have a goal of home SBP <135mmHg. The Standard BP protocol is designed to achieve a home SBP of 130-134 mmHg in as many participants as possible. Following the randomization visit, medication dose titration or addition of another drug is indicated if home SBP ≥135 mmHg. Monthly visits will continue in the Standard Group when home SBP ≥155 mmHg. Down titration (a reduction of the dose or number of antihypertensive drugs) should be carried out if the home SBP is <125 mmHg.
干预措施: Standard BP Control (Drug)
结局指标
主要结局
Hierarchical composite cardiovascular outcomes
时间窗: 5 years
a hierarchical composite of cardiovascular death, number of strokes, time to first stroke, number of MI, time to first MI, number of HF, and time to first HF
次要结局
- Main secondary cardiovascular outcomes(5 years)
- Main secondary renal outcomes(5 years)
- All-cause mortality(5 years)
- Change of the concern of falling(5 years)
- Change of the health state utility(5 years)
- Change of the self-report depression(5 years)
- Change of the self-report anxiety(5 years)
- Change of the frailty(5 years)
研究者
Chang sheng Ma
Director of Cardiology
Beijing Anzhen Hospital