EXpanded Combination of Evolocumab Plus Empagliflozin on Diabetes: EXCEED-BHS3 Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Difference in the percentage change in flow mediated dilation (FMD)
研究概览
简要总结
Based on the current evidence, empagliflozin could reduce cardiovascular morbidity and mortality in Diabetes Mellitus Type 2 (T2DM). Anti-PCSK9 therapy (evolocumab) can reduce the major cardiovascular events incidence in secondary prevention individuals, some of them presenting T2DM. The beneficial effect of the combined use of these two agents in T2DM remains unknown. Evaluating the effect of evolocumab on top of the best of care therapy for T2DM, including empaglifozin, on endothelial function may indicate the existence of some benefit related to cardiovascular outcomes.
详细描述
Study design: Randomized, parallel-group, open, comparative, prospective clinical study.
Eligibility criteria will be: T2DM between 40 and 70 years old; adequate glycemic control; (HbA1c 7 to 9%) after run-in phase; adequate blood pressure control (SBP ≤ 140 mm Hg); maximal tolerated dose of statins and LDL-C between 70 and 100 mg/dL.
Volunteers' convocation -Investigators will announce in radio, television and newspapers inviting volunteers with T2DM for this study. Those who contact us with an interest in participating by email or whatsapp will be enrolled for the first telephone screening evaluation. These volunteers will be contacted by phone and after a detailed explanation about the objectives, procedures, and shared responsibilities between the parties those willing to participate will be summoned to a Screening Visit (SV) in which inclusion and exclusion criteria will be further verified. The screening FMD will be measured in this occasion.
Run-In - In the following two weeks after the screening visit, patients must return to another consultation in which antidiabetic, antihypertensive and lipid-lowering therapies adjustment will be performed. The adjustment period must be ended at 16 weeks and if this is not so patients will be excluded.
Pre-randomization exams - In the two weeks preceding the Randomization Visit, patients will undergo laboratory tests (urea, creatinine, blood glucose, total cholesterol, HDL-c, LDL-col, HbA1c, triglycerides).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2DM between 40 and 70 years old;
- •Adequate glycemic control (HbA1c 7 to 9%) after run-in phase;
- •Adequate blood pressure control (SBP ≤ 140 mm Hg)
- •Maximal tolerated dose of statins and LDL-C between 70 and 100 mg/dL.
排除标准
- •HbA1c > 9% after run-in phase;
- •Hospitalization for unstable angina or acute myocardial infarction within 6 months prior to enrolment;
- •Acute stroke or transient ischemic attack (TIA) within 6 months prior to enrolment;
- •Less than two months post coronary artery revascularization;
- •BP ≥ 140 x 90 after anti-hypertensive medication adjustment;
- •FMD <2% or > 10% at the time of randomization;
- •Triglycerides > 500 mg/dL;
- •Known allergy to any of the study drugs;
- •Severe coronary artery disease or heart failure;
- •Systemic inflammation (C-reactive protein ≥ 5 mg/dL);
- •Pregnancy or women during reproductive age;
- •Active smoking or stopped smoking less than six months ago;
- •Participation in other clinical studies or whose participation ended less than six months -ago.
- •Use of SGLT2i or GLP-1a in the last sex months
研究组 & 干预措施
Evolocumabe
Patients with T2DM treated with the standard of care (SGLT2 inhibitors, maximal statin dose and ideal control of blood glucose and blood pressure) AND evolocumab (anti-PCsk9).
干预措施: Evolocumab 140 MG/ML (Drug)
结局指标
主要结局
Difference in the percentage change in flow mediated dilation (FMD)
时间窗: 16 weeks
Difference in the change in flow mediated dilation (FMD) between the randomization visit and at 16 weeks of treatment. Brachial artery measurements will be performed using a high-resolution ultrasound obtained by physicians with long experience in this exam. The FMD scan will be measured on Video clips recorded from 1 minute before cuff inflation to 5 minutes after deflation. Percentage change in diameter for FMD will be calculated in relation to the respective baseline scans.
次要结局
- Difference in the percentage change in FMD reserve(16 weeks)
研究者
Andrei Carvalho Sposito
Coordinator of the Brazilian Heart Study Group
University of Campinas, Brazil