2024-516643-64-00招募中3 期
DIAMOND Study - DIrect oral anticoagulant for Antithrombotic Management Of aortic bioprothesis implanted patients for valvular heart Disease Study
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 19
- 主要终点
- The primary endpoint is a composite efficacy endpoint including death, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis. The primary endpoint will be evaluated at the end of the treatment (105±15 days after inclusion and randomization).
研究概览
简要总结
• To demonstrate that antithrombotic treatment with apixaban is superior to aspirin in patients with recent surgical bioprosthetic aortic valve replacement for the primary composite efficacy endpoint of death, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years of age
- •Prior implantation of a bioprosthesis in the aortic position at least 7 days and before hospital discharge
- •Participants currently not requiring chronic anticoagulation for another reason (atrial fibrillation, pulmonary embolism or any other condition)
- •Patients affiliated to social security
- •Patient able to give free, informed and written consent
排除标准
- •Cardiac surgery less than 7 days prior to enrollment or more than 1 month
- •Known hypersensitivity or other contraindications to heparin or low molecular weight heparin (history of heparin-induced thrombocytopenia, hypersensitivity to any of the excipients…)
- •Ischemic stroke within 1 month or intracranial hemorrhage
- •Active endocarditis at the time of screening for enrollment.
- •Women of childbearing potential without efficient contraception, pregnant or breastfeeding women.
- •Concomitant combined strong P-gp and CYP3A4 inducers or inhibitors.
- •History of non-compliance
- •Participation in another interventional study
- •Active cancer or life expectancy less than 1 year
- •Persons deprived of their liberty by judicial or administrative decision
- •Mechanical valve in any position or combined valve surgery (mitral or tricuspid).
- •Any major bleeding in the three months (90 days) prior to enrollment.
- •Active bleeding or high risk of bleeding after cardiac surgery (i.e. hemopericardium) or lesion or condition considered as a significant risk factor for major bleeding according to investigator
- •Atrial fibrillation requiring chronic anticoagulation
- •Need to be on dual antiplatelet therapy (aspirin >100 mg daily and a P2Y12 inhibitor, i.e. clopidogrel, ticagrelor, prasugrel) or requiring chronic anticoagulation whatever the treatment (oral or injection).
- •Known hypersensitivity or other contraindications to apixaban (hepatic disease associated with coagulopathy and clinically relevant bleeding risk).
- •Creatinine clearance <40 mL/min (Cockcroft) or patients requiring apixaban dose reduction.
- •Known hypersensitivity or other contraindications to aspirin (Hypersensitivity to aspirin or any of the excipients, history of asthma induced by the administration of salicylates, ongoing peptic ulcer, constitutional or acquired hemorrhagic disease including gastrointestinal bleeding, history of hemorrhagic stroke and thrombocytopenia, pregnancy after 24 weeks of gestation, risk of bleeding, severe renal failure, severe hepatic impairment, uncontrolled severe heart failure
结局指标
主要结局
The primary endpoint is a composite efficacy endpoint including death, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis. The primary endpoint will be evaluated at the end of the treatment (105±15 days after inclusion and randomization).
The primary endpoint is a composite efficacy endpoint including death, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis. The primary endpoint will be evaluated at the end of the treatment (105±15 days after inclusion and randomization).
次要结局
- Bleeding (primary safety endpoint) : ISTH major bleeding
- Bleeding with ISTH bleeding scale : o ISTH major bleeding o ISTH non-major clinically relevant bleeding
- Bleeding with the TIMI bleeding scale : o TIMI major bleeding o TIMI minor bleeding
- Bleeding with the BARC definition (BARC 3 to 5)
- Composite efficacy endpoints including: All-cause death, Myocardial infarction (Fourth Universal Definition of Myocardial Infarction), Stroke, Systemic embolism, Deep vein thrombosis, Pulmonary embolism, Valve thrombosis
- All-cause death
- Aortic valve thrombosis (adapted from VARC-3 definition)
- Mean aortic gradient (mmHg) and peak velocity (m/s)
研究者
Jean-Guillaume DILLINGER
Scientific
Assistance Publique Hopitaux De Paris
研究点 (19)
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