EUCTR2006-004449-40-NL进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination with Aspirin Alone or with Aspirin and a Thienopyridine in Subjects with Acute Coronary Syndromes (39039039ACS2001)The ATLAS ACS TIMI 46 Trial (Anti-Xa Therapy to Lower cardiovascular events in addition to Aspirin with or without thienopyridine therapy in Subjects with Acute Coronary Syndrome) - The ATLAS ACS TIMI 46 Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
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
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •- man or woman between 18 and 75 years of age, inclusive, for Stage 1. For Stage 2, subjects over 75 years of age will be allowed to enroll assuming an acceptable safety profile is demonstrated in Stage 1.
- •- female subjects must be surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study; female subjects of childbearing potential must have a negative urine ß-hCG pregnancy test at screening.
- •- subjects must have signed an informed consent document.
- •- in countries where health authorities have approved the pharmacogenomic testing, subjects must have signed an informed consent for genetic testing indicating that they agree to participate in the genetic part of the study; participation in the genetic testing component is not mandatory for participation in the study.
- •- have symptoms suggestive of ACS that lasted at least 10 minutes at rest occurring within 7 days of randomization
- •- have either a diagnosis of STEMI or a diagnosis of NSTEMI or UA with at least 1 of the follow:
- •- elevated cardiac enzyme marker (e.g., CK-MB or troponin I or T)
- •- =1 mm ST-segment deviation (i.e., elevation or depression)
- •- TIMI risk score =3
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Conditions that may increase the risk of bleeding:
- •- active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis within 30 days of randomization
- •- platelet count <90,000/µL at the screening visit
- •- known pseudoaneurysm
- •- major surgery, biopsy of a parenchymal organ, eye surgery (including cataract surgery or vision correcting surgery), or serious trauma within 30 days before randomization
- •- clinically significant gastrointestinal bleeding within 6 months before the randomization visit
- •- have an INR known to be >1.5 at the time of screening
- •- abciximab bolus or infusion within the past 8 hours, or an eptifibatide or tirofiban bolus or infusion within the past 2 hours before randomization
- •- any other condition known to increase the risk of bleeding
- •Conditions that may increase the risk of intracranial hemorrhage:
- •- history of hemorrhagic stroke at any time or clinical presentation consistent with intracranial hemorrhage (e.g., severe headache or new neurologic deficit after fibrinolytic therapy)
- •- recent ischemic stroke or transient ischemic attack (TIA) of any etiology within 30 days of randomization
- •- recent head trauma. (i.e., within 30 days of randomization)
- •- known intracranial neoplasm, arteriovenous malformation, or aneurysm
- •- sustained uncontrolled hypertension: systolic blood pressure of =180 mmHg or diastolic pressure of =100 mmHg that persists for more than 1 hour at time of screening despite treatment
- •Required drugs or procedures:
- •- the need for continued treatment with anticoagulant drugs (e.g., warfarin)
- •- systematic treatment with a strong inhibitor of cytochrome P450 3A4, such as ketoconazole or protease inhibitors, within 4 days before randomization or planned treatment during the time period of the study
- •- treatment with a strong inducer of cytochrome P450 3A4, such as rifampin/rifampicin within 4 days before randomization or planned treatment during the time period of the study
- •- planned PCI or peripheral arterial intervention
- •Severe concomitant diseases such as:
- •- cardiogenic shock
- •- refractory ventricular arrhythmias
- •- calculated creatinine clearance <30 mL/min at the screening visit
- •- known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis), or ALT >3 times the ULN
- •- anemia (i.e., hemoglobin <10 g/dL) at the screening visit
- •- have received transfusion of red blood cells (RBCs), whole blood, or platelets within 7 days before randomization
- •- known human immunodeficiency virus (HIV) infection at the screening visit
- •- substance abuse (drug or alcohol) problem within the previous 3 years
- •- have any severe condition that would limit life expectancy to less than 6 months
- •- known allergy to aspirin
- •- known allergy or hypersensitivity to any component of rivaroxaban or placebo excipients (includes lactose, microcrystalline cellulose, magnesium stearate, hypromellose, macrogol, croscarmellose sodium, sodium lauryl sulfate, titanium oxide/ferric oxide red)
- •- have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment
- •- is pregnant or breast-feeding or planning to become pregnant during the study
- •- have previously completed or withdrawn from this study or any other study of rivaroxaban
- •- employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study ce
研究者
相似试验
已完成
1 期
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of the Safety, Pharmacokinetics and Efficacy of CBP-201 in adult patients with Atopic DermatitisAtopic DermatitisACTRN12619000395134Connect Biopharma Australia Pty Ltd31
进行中（未招募）
1 期
A Clinical Trial to look at the Safety, Tolerability and Efficacy of the Drug Product GS-9876 on patients with Rheumatoid Arthritis who are also being treated with Methotrexate.MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid ArthritisEUCTR2016-001496-75-PLGilead Sciences, Inc.80
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults taking Opioid Therapy for Persistent Non-Cancer PaiEUCTR2005-001723-10-EEGlaxoSmithKline R & D Limited480
进行中（未招募）
1 期
A Phase 3 study in Patients with Type 2 Diabetes MellitusMedDRA version: 18.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersType 2 Diabetes MellitusEUCTR2012-002414-39-SEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.4,202
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled, Multicentre,Phase II Study of Oral Lapatinib in combination with ConcurrentRadiotherapy and Cisplatin versus Radiotherapy and Cisplatinalone, in Subjects with Stage III and IVA,B Squamous CellCarcinoma of the Head and Neck (SCCHN)Estudio de fase II, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de lapatinib oral en combinación con radioterapia concomitante y cisplatino frente a radioterapia y cisplatino solo, en pacientes con carcinoma epidermoide de cabeza y cuello (SCCHN) de estadio III y IVA,B.Stage III, IVa, IVb Squamous Cell Carcinoma of the Head & NeckCarcinoma epidermoide de cabeza y cuello estadíos III,IVa,IVb.MedDRA version: 8.1Level: LLTClassification code 10041823EUCTR2005-003767-23-ESGlaxoSmithKline S.A.120