EUCTR2017-000552-25-HU进行中（未招募）1 期
Evaluation of Safety and Thrombolytic Effect of Ascending Doses of DS-9231 (TS23) in Subjects with Intermediate-Risk (sub-massive) Acute Pulmonary Embolism (PE)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 104
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female subjects, age >18 years;
- •2. PE involving a segmental or more proximal pulmonary artery confirmed by CTPA scan and with an onset of symptoms not more than 5 days prior to diagnosis;
- •3. Subject is hemodynamically stable with a systolic blood pressure (SBP) >90 mm Hg
- •4. Subject has evidence of RV dysfunction (at least one of the following):
- •Right ventricular-to-left ventricular (RV/LV) diameter ratio > 0.9 on CTPA scan (measuring the minor axis of the right and left ventricle in the transverse plane),
- •or myocardial injury as evidenced by an elevated cardiac Troponin T or Troponin I (using the test of the local laboratory of Clinical Chemistry at the participating site). An abnormal value is that above the 99th percentile of the healthy population as a cutoff using an assay with acceptable precision. The 99th percentile cutoff point for cardiac Troponin T (cTnT) is well-known at 0.01 ng/mL as only one cTnT assay exists. In contrast, several different assays are commercially available for cardiac Troponin I (cTnI), so the 99th percentile cut point varies based on the assay being used. Please refer to Appendix 17.3 as guideline for acceptable abnormal Troponin I values.
- •or RV/LV ratio > 0.9 on echocardiogram (apical or subcostal 4 - chamber view echocardiogram). A trained cardiac sonographer may not be available during non-business hours (for emergency admissions); however, if feasible, obtain echocardiogram prior to the initiation of study drug administration.
- •Eligible subjects, who qualify and have executed informed consent, will be randomized as early as possible and every effort will be made to administer the study medication (DS-9231 versus placebo) as soon as possible within the first 6 hours after the randomization
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 52
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 52
排除标准
- •1. Subjects for whom thrombolytic therapy or thrombectomy is planned; or subjects with history of administration of thrombolytic agents within the previous 4 days;
- •2. Subjects receiving = 48 hours of therapeutic doses of heparin or LMWH or other anticoagulant therapy immediately prior to randomization;
- •3. Subjects with contraindications to SOC therapies such as unfractionated heparin or LMWH or oral anticoagulant, or any of the excipients (including study drug excipients);
- •4. Subjects who are considered at very high risk of bleeding:
- •a. Known coagulation disorder with history of pathologic bleeding tendencies
- •b. Subjects with prior intracranial hemorrhage, known arteriovenous malformation or aneurysm of the
- •brain, or evidence of active bleeding;
- •c. Subjects with a history of major surgery, clinically significant head trauma (in the opinion of the
- •Principal Investigator), or stroke in the past 3 months prior to randomization;
- •d. Subjects with uncontrolled hypertension defined as SBP =180 mm Hg and/or diastolic BP
- •(DBP) =110 mm Hg at randomization
- •e. Subjects requiring concomitant dual antiplatelet therapy
- •5. Subjects with Creatinine Clearance (CrCL) < 30 mL/min or serum creatinine = 2.5 mg/dL;
- •6. Subjects with hemoglobin < 8.0 g/dL;
- •7. Subjects with a platelet count < 100,000/µL;
- •8. Subjects with acute or persistent hepatitis or diagnosed active liver disease or with elevation of liver enzymes: Alanine transaminase (ALT) or aspartate transaminase (AST) = 3 x upper limit of normal (ULN);
- •9. Subjects with known history of testing positive for Hepatitis B antigen or Hepatitis C antibody;
- •10. Subjects with known history of testing positive for the human immunodeficiency virus (HIV);
- •11. Subjects with life-expectancy < 6 months;
- •12. Female subjects of child bearing potential with a positive pregnancy test or who are lactating, or unwilling to use highly effective methods of contraception. Highly effective methods of birth control include combination hormonal therapy (estrogen and progresterone), contraceptives administered orally, intravaginally or transdermally, progesterone-only contraceptives administered orally, by injection or implantation, use of an intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, partner vasectomy or sexual abstinence;
- •13. Subjects currently participating in another investigational study or who have participated in an investigational drug study within 30 days (or longer depending on the half-life of the investigational drug; should allow at least five half-life of the investigational drug) prior to randomization.
研究者
相似试验
已完成
不适用
Evaluation of the efficacy and safety of thromboprophylaxis regimens in patients after the Fontan procedurePatients after the Fontan procedureJPRN-UMIN000044127Showa University1,903
已完成
不适用
A Study of Safety and efficacy of anticoagulant therapy in the treatment of Atrial Fibrillation in KANAGAWAAtrial fibrillationJPRN-UMIN000011830ASSAF-K steering committee5,000
已完成
不适用
Assessment of anti-thrombotic effects of conventional anti-thrombotic therapy using total thrombus-formation analysis system in transcatheter aortic valve replacementAortic stenosisJPRN-UMIN000041165Teikyo University120
已完成
2 期
Platenza Tablets for Dengue feverCTRI/2018/02/011789The Himalaya Drug Company40
已完成
不适用
Efficacy and safety of Antithrombin III administration for the patients with blood coagulation disorder after hepatectomy.Blood coagulation disorder after hepatectomyJPRN-UMIN000018852Gasroenterological Surgery, Hiroshima University Hospital140