Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion SUBTITLE Prevention of Cardiovascular Death, Heart Failure Events and Deterioration in Quality of Life With INtravenous FERRic Carboxymaltose in Iron Deficient Patients With Recent Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 43
- 主要终点
- Time to all-cause death assessed up to maximum 36-months follow-up;
研究概览
简要总结
Non-commercial, multicentre, randomised, double-blind, parallel group, placebo-controlled clinical trial. Eligible patients were randomly assigned (1:1) using a secure, central, interactive, web-based response system, to intervention FCM or placebo arm. Time of observation: minimum of 8 months up to a maximum of 36 months.
Primary Study Objective: Primary:
Evaluation of the effect of i.v. FCM treatment compared with placebo on the risk of death, the risk of heart failure events (HFE*) (number of events and time to first event), NTproBNP concentration and the change in quality of life (QoL) assessed using EQ-5D during the follow-up up to 36-months in patients with recent AMI and ID (with an implementation of a win ratio approach in a hierarchical descending order).
*HFE: unplanned hospitalization for HF (including unplanned visit at emergency department due to HF), ambulatory significant intensification of diuretic therapy (either starting i.v. loop diuretic or more than doubling oral loop diuretic dose or de novo initiation of oral loop diuretic therapy due to HF signs/symptoms).
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
A drip will be prepared by unblinded personnel using masked bottle, light brown lines for infusion, and administered immediately after preparation using a special curtain (screen).
入排标准
- 年龄范围
- 18 Years 至 90 Years（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
Active
an i.v. 15-minute infusion of 20 mL Ferinject (containing 1000 mg of FCM) diluted in 50 mL of NaCl 0.9%
干预措施: Ferinject (Drug)
Placebo
70 mL of i.v. NaCl 0.9% infusion
干预措施: Sodium Chloride 0.9% Inj (Drug)
结局指标
主要结局
Time to all-cause death assessed up to maximum 36-months follow-up;
时间窗: up to 36 months
Defined as: (with an implementation of a win ratio approach in a hierarchical descending order): 1. Time to all-cause death assessed up to maximum 36-months follow-up; 2. Number of HFE assessed up to maximum 36-months follow-up; 3. Time to first HFE assessed up to maximum 36-months follow-up; 4. Changes in serum NT-proBNP concentration from the start of the follow-up to the end of participation in the study assessed as the area under the curve; 5. Changes in quality of life (QoL) measured using the EQ-5D questionnaire from the start of the follow-up to the end of participation in the study assessed as the area under the curve. * HFE: unplanned hospitalization for HF (including unplanned visit at emergency department due to HF), ambulatory significant intensification of diuretic therapy (either starting i.v. loop diuretic or more than doubling oral loop diuretic dose or de novo initiation of oral loop diuretic therapy due to HF signs/symptoms).
Time to first HFE assessed up to maximum 36-months follow-up
时间窗: up to 36 months
Time to first HFE
Changes in serum NT-proBNP concentration from the start of the follow-up to the end of participation in the study assessed as the area under the curve
时间窗: up to 36 months
Changes in serum NT-proBNP
Number of HFE assessed up to maximum 36-months follow-up
时间窗: up to 36 months
Number of HFE
Changes in quality of life (QoL) measured using the EQ-5D questionnaire from the start of the follow-up to the end of participation in the study assessed as the area under the curve
时间窗: up to 36 months
Changes in quality of life
次要结局
- CV death during the follow-up(up to 36 months)
- All unplanned HF hospitalisations and unplanned visit at emergency department due to HF and CV death during the follow-up (recurrent event model);(up to 36 months)
- All unplanned HF hospitalisations during the follow-up (recurrent event model);(up to 36 months)
- First unplanned HF hospitalisation or unplanned visit at emergency department due to HF or CV death during the follow-up (time-to-event model)(up to 36 months)
- All unplanned HF hospitalisations and unplanned visit at emergency department due to HF during the follow-up (recurrent event model)(up to 36 months)