Tacrolimus In Combination, Tacrolimus Alone Compared (TICTAC Trial): A Prospective Randomized Trial Of Minimized Immunosuppression In Adult Heart Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation
研究概览
简要总结
This was a study to compare less intense immunosuppression with a more traditional approach. The hypothesis was that less immunosuppression will provide similar protection against rejection than typical 2-3 drug therapy.
详细描述
This was a prospective, randomized, controlled (open-label) trial of 2 different strategies of immunosuppression in de novo post-heart transplant patients. The hypothesis was that immunosuppression with tacrolimus and mycophenolate mofetil, coupled with rapid steroid weaning would provide similar anti-rejection efficacy as tacrolimus with only a 2 week course of mycophenolate mofetil but including the same rapid steroid wean.
The primary endpoint was the mean International Society for Heart and Lung Transplantation (ISHLT) biopsy score over the first 6 months post-transplant. Secondary endpoints included the incidence of adverse events over the first year post-transplant, as well as all-cause mortality, 12 month ISHLT biopsy score (mean), along with the incidence of proven cytomegalovirus disease. In addition, the incidence of allograft vasculopathy as assessed by angiography or intravascular ultrasound was compared between groups.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (at least 18 years old)
- •Undergoing a first heart transplant (no heart/kidney transplants), who receive their transplant at one of the study sites
- •Specifically INCLUDED are patients on ventricular assist devices, and allosensitized recipients
排除标准
- •Age less than 18
- •Inability to provide proper informed consent
- •Combined organ transplantation
- •Re-Transplantation
研究组 & 干预措施
Monotherapy
Tacrolimus alone
干预措施: Tacrolimus (Drug)
Combination therapy
tacrolimus with mycophenolate mofetil
干预措施: Tacrolimus (Drug)
Combination therapy
tacrolimus with mycophenolate mofetil
干预措施: combination therapy (Drug)
结局指标
主要结局
Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation
时间窗: 6 months
Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6.
次要结局
- Percent of Patients Alive at One Year Post-transplant(1 year)
- Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant(1 year)
- Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant(1 year)
- Mean ISHLT Biopsy Score Over First Year Post-transplant(1 year)
研究者
David A. Baran, MD
Director, Heart Failure and Transplant Research
Newark Beth Israel Medical Center