Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction Treated With Percutaneous Coronary Intervention - The Dan-DAPT Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,808
- 试验地点
- 12
- 主要终点
- BARC type 2-5 bleedings
研究概览
简要总结
Rationale: Heart attacks are a major cause of death and result from coronary blood clots that require acute coronary intervention and antithrombotic drugs to restore blood flow and prevent new heart attacks. Over time, more potent antithrombotic drugs have been introduced like prasugrel and ticagrelor. These drugs have replaced the older drug, clopidogrel, as approximately 30% of patients are low-responders to clopidogrel for genetic reasons. However, the newer drugs introduce a significant risk of serious bleeding.
Aim: The aim of this trial is to assess a reduced antithrombotic strategy for high bleeding risk patients with heart attacks to reduce bleeding safely.
Hypothesis: Significantly reduced bleeding with a similar preventive effect are expected.
Design: The Dan-DAPT trial include high bleeding risk patients with heart attacks from Danish hospitals (Rigshospitalet, Aarhus, Odense, Aalborg, Roskilde, and Gentofte hospital) and randomize them to standard-of-care or shorter and individualized antithrombotic therapy based on responsiveness to clopidogrel after genetic testing.
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
- •MI caused by atherothrombotic CAD (Type 1 MI) according to "The Fourth Universal Definition of MI", which has been treated with PCI with contemporary drug-eluting stents. This definition of type 1 MI requires the detection of a rise and/or fall of cardiac troponin values with at least one value >99th percentile and at least one of the following criteria assessed by the treating physician:
- •symptoms indicating acute myocardial ischemia
- •new ischemic changes on the electrocardiogram
- •development of pathological Q-waves
- •imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology
- •visible coronary thrombus by angiography
- •PRECISE-DAPT score ≥25
- •Age ≥18 years
排除标准
- •Contraindications including allergies to ASA or P2Y12 inhibitors
- •Indication for oral anticoagulation
- •Previous stent thrombosis
- •Life expectancy <1 year
- •Resuscitated cardiac arrest with Glasgow Coma Scale <8 and/or need of intubation
- •Prior intracranial hemorrhage
- •Active bleeding (BARC ≥2) at randomization
- •Women who are pregnant, have given birth recently (within the past 90 days), are lactating, or are fertile without contraception
- •Hypertensive crisis (systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg)
- •Unable to understand and follow study-related instructions or to comply with study protocol
研究组 & 干预措施
Standard-of-care DAPT
Dual antiplatelet therapy (DAPT) with acetylsalicylic acid (ASA) and prasugrel or ticagrelor for 6 months followed by ASA monotherapy.
Genotype-guided DAPT
DAPT according to CYP2C19*2/*3-genotyping for 6 months followed by ASA monotherapy.
干预措施: CYP2C19*2/*3 (Genetic)
Shorter genotype-guided DAPT
DAPT according to CYP2C19*2/*3-genotyping for 3 months followed by ASA monotherapy.
干预措施: CYP2C19*2/*3 (Genetic)
Shorter genotype-guided DAPT
DAPT according to CYP2C19*2/*3-genotyping for 3 months followed by ASA monotherapy.
干预措施: Shorter DAPT duration (Other)
结局指标
主要结局
BARC type 2-5 bleedings
时间窗: 1 year
A composite of type 2-5 non-access site bleeding according to the Bleeding Academic Research Consortium (BARC) scale, ranging from bleedings that require diagnosis, hospitalization, or treatment by a health care professional (BARC type 2) to fatal bleedings (BARC type 5)
NACE (Net adverse clinical events)
时间窗: 1 year
A composite of all-cause mortality, recurrent myocardial infarction, definite stent thrombosis, ischemic stroke, and BARC type 3-5 non-access site bleeding
次要结局
- Non-hemorrhagic cardiovascular death(3, 6, and 12 months)
- All-cause mortality(3, 6, and 12 months)
- MACE (Major adverse cardiovascular events)(3, 6, and 12 months)
- Ischemic events(3, 6, and 12 months)
- Pharmacoeconomic endpoint including direct and in-direct medical costs(3, 6, and 12 months)
- Discontinuation or switch to another antiplatelet drug(3, 6, and 12 months)
- Bleedings according to BARC and TIMI (Thrombolysis in Myocardial Infarction) defintions(3, 6, and 12 months)
- Self-reported quality of life scores(3, 6, and 12 months)
研究者
Rikke Sorensen
MD, Ph.D.
Rigshospitalet, Denmark