NL-OMON56449尚未招募3 期
Pulmonary Embolism International Thrombolysis Trial: A reduced dose of thrombolytic treatment for patients with intermediate high-risk acute pulmonary embolism: a randomized controlled trial. - PEITHO-3
Assistance Publique - Hôpitaux de Paris, Clinical Research and Innovation Direction (DRCI)0 个研究点目标入组 75 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age 18 years or older;
- •* Objectively confirmed acute PE with first symptoms occurring 2 weeks or less
- •before randomization. Objective confirmation is based on at least one of the
- •following criteria: (a) at least one segmental ventilation-perfusion mismatch
- •on lung scanning; (b) computed tomography pulmonary angiography (CTPA) or
- •selective pulmonary angiography showing a filling defect or an abrupt
- •obstruction of a segmental or more proximal pulmonary artery;
- •* *cute PE confirmed within 24 hours prior to randomization;
- •* Elevated risk of early death, or of hemodynamic collapse, or PE recurrence,
- •indicated by at least one of the following criteria: (a) systolic blood
- •pressure (SBP) <= 110 mm Hg over at least 15 min upon enrolment, (b) temporary
- •need for fluid resuscitation and/or treatment with low dose catecholamines
- •because of arterial hypotension at presentation, provided that the patient
- •could be stabilized within 2 hours of admission and maintains SBP of >= 90 mm Hg
- •and adequate organ perfusion without catecholamine infusion; (c) respiratory
- •rate > 20/min or SpO2 < 90% (or partial arterial oxygen pressure < 60 mm Hg) at
- •rest while breathing room air, (d) documented history of chronic symptomatic
- •heart failure defined as previous diagnosis of heart failure (i.e. heart
- •failure with reduced, moderately reduced or preserved ejection fraction), or
- •treatment for heart failure at any time during the past 12 months;
- •* RV dysfunction indicated by RV/LV diameter ratio > 1.0 on echocardiography
- •apical four-chamber or subcostal four-chamber view or on CTPA (transverse
- •* Serum troponin I or T concentration above the upper limit of local normal
- •using a high-sensitivity assay;
- •* Ability to randomize the patient within 6 hours after the investigator
- •receives the result of the second of the two criteria for RV dysfunction (RV/LV
- •diameter ratio > 1.0) and myocardial injury (serum troponin I or T
- •concentration above the upper limit of local normal), whichever comes latest;
- •* Signed informed consent form;
- •* [France] Patient insured under a social security system
排除标准
- •* Hemodynamic instability, defined by at least one of the following criteria
- •- cardiac arrest;
- •- obstructive shock, defined as: (i) SBP < 90 mm Hg, or vasopressors required
- •to achieve a SBP >= 90 mmHg despite an adequate filling status; and (ii)
- •end-organ hypoperfusion (altered mental status; cold, clammy skin;
- •oliguria/anuria; increased serum lactate);
- •- isolated persistent hypotension (SBP < 90 mm Hg, or a systolic pressure drop
- •>= 40 mm Hg for > 15 min), if not caused by new-onset arrhythmia, hypovolemia,
- •* Active bleeding
- •* History of non-traumatic intracranial bleeding, any time
- •* Acute ischemic stroke or transient ischemic attack (TIA) within the previous
- •* Known central nervous system neoplasm/metastasis
- •* Neurologic, ophthalmologic, abdominal, cardiac, thoracic, vascular or
- •orthopedic surgery or trauma within the previous 3 weeks
- •* Platelet count < 100 x 109/L
- •* INR > 1.4. If INR not available: prothrombin time ratio < 60%. If both INR
- •and prothrombin time ratio are measured, INR is relevant for the assessment of
- •this criterion.
- •* Treatment with antiplatelet agents other than (a) acetylsalicylic acid (ASA)
- •<= 100 mg once daily or (b) clopidogrel 75 mg once daily or (c) a single loading
- •dose of ASA or clopidogrel. Dual anti-platelet therapy (ASA + clopidogrel) is
- •not allowed.
- •* Any direct oral anticoagulant within 12 hours of inclusion
- •* Uncontrolled hypertension defined by SBP > 180 mm Hg at the time of inclusion
- •* Known pericarditis or endocarditis
- •* Known significant bleeding risk according to the investigator*s judgement
- •* Administration of thrombolytic agents within the previous 4 days
- •* Vena cava filter insertion or pulmonary thrombectomy within the previous 4
- •* [Italy and the Netherlands] Participation in another interventional clinical
- •study within 30 days from the inclusion
- •* [All countries except Italy and the Netherlands] Current participation in
- •another interventional clinical study
- •* Previous enrolment in this study
- •* Known hypersensitivity to alteplase, gentamicin (a residue of the Actilyse®
- •manufacturing process present in trace amounts), any of the excipients of
- •Actilyse®, or low-molecular weight heparin (LMWH)
- •* Known previous immune heparin-induced thrombocytopenia
- •* Known severe liver disease (grade >= 3) including liver failure, cirrhosis,
- •portal hypertension (esophageal varices) and active hepatitis
- •* Acute symptomatic pancreatitis
- •* Gastrointestinal ulcers or esophageal varices, documented within the past 3
- •* Known arterial aneurysm, arterial or venous malformations
- •* Pregnancy or parturition within the previous 30 days or current breastfeeding
- •* Women of childbearing potential who do not have a negative pregnancy test at
- •the inclusion visit and do not use one of the following methods of birth
- •control: hormonal contraception or intrauterine device or bilateral tubal
- •* Any other condition that in the investigator*s opinion would place the
- •patient at increased risk upon start of the investigational treatment
- •* Life expectancy of less than 6 months, or inability to complete 6-month
- •follow-up.
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