CTRI/2010/091/000233已完成3 期
"Randomized, double-blind, triple-dummy trial to compare the efficacy of otamixaban with Unfractionated Heparin + eptifibatide, in patients with Unstable angina/Non ST segment Elevation Myocardial infarction scheduled to undergo an early invasive strategy"
SanofiSynthelabo India Limited35 个研究点 分布在 1 个国家目标入组 10,930 人开始时间: 2010年1月4日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10,930
- 试验地点
- 35
- 主要终点
- Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction
研究概览
简要总结
Trial will be conducted in 52 countries all over the world.
Up to the interim analysis, patients are randomized to one of the Otamixaban arms or the control arm (UFH + Eptifibatide). Then after interim analysis, patients will be randomized to the continued Otamixaban arm (per Data Monitoring Committee (DMC) decision based on interim analysis results) or the control arm (UFH + Eptifibatide). Except the DMC, all participants will remain blinded to this decision until the end of study.
The total duration of the study period per subject will range between 30 days and 180 days. Study end date being the Day 30 visit of the last randomized patient, follow up will be until Day 180 or study end date whichever comes first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •"Inclusion Criteria: Patient with non STE-segment elevation Acute Coronary Syndrome with the following symptoms: Ischemic symptoms (chest pain or equivalent) at rest ≥10 minutes within 24 hours of randomization AND One of the two following criteria: A.
- •New ST-segment depression ≥0.1 mV (≥1 mm), or transient (<30 minutes) STsegment elevation ≥0.1 mV (≥1 mm) in at least 2 contiguous leads on the ECG, OR B.
- •Elevation of cardiac biomarkers within 24 hours of randomization, defined as elevated troponin T, troponin I, or CK-MB level above upper limit of normal AND Planned to have a coronary angiography (followed, when indicated, by PCI) as early as possible (after at least 2 hours of treatment with study drug) and within 36 hours (at the latest on Day 3, if justified) AND Informed consent obtained in writing Exclusion Criteria:
- •Exclusion criteria related to study methodology A.
- •High likelihood of being unavailable for the Day 180 follow up
- •Age <18 years old (or country?s legal age of majority)
- •Pregnancy, as evidenced by a positive urine pregnancy test performed prior to randomization (applicable only to women of childbearing potential, ie, women who are pre-menopausal or <2 years post-menopausal)
- •Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization, or planned use of investigational agents or devices during the study duration
- •Breastfeeding B.
- •Cardiovascular
- •Revascularization procedure already performed for the qualifying event.
- •Acute ST-segment elevation MI C.
- •Related to prior or concomitant treatments
- •Patient having received curative dose of anticoagulant treatment (including UFH, LMWH, or bivalirudin) for more than 24 hours prior to randomization.
- •Inability to discontinue current anticoagulation in order to transition to Investigational Products according to the specified transition timing
- •Patients who can not be treated by aspirin and clopidogrel (or any other oral antiplatelet agent) according to their local labeling
- •Exclusion criteria related to the active comparator and/or mandatory background therapies A.
- •Related to eptifibatide
- •Patient who cannot be treated with eptifibatide according to the national labeling (when available).
- •In countries where eptifibatide is not approved the reference label to be considered will be either the European labeling or the US labeling (see Appendix H and Appendix I).
- •Related to unfractionated heparin
- •Patient who cannot be treated with unfractionated heparin according to the national labeling C.
- •Related to otamixaban
- •Allergy to otamixaban ".
排除标准
- •"Inclusion Criteria: Patient with non STE-segment elevation Acute Coronary Syndrome with the following symptoms: Ischemic symptoms (chest pain or equivalent) at rest ≥10 minutes within 24 hours of randomization AND One of the two following criteria: A. New ST-segment depression ≥0.1 mV (≥1 mm), or transient (<30 minutes) STsegment elevation ≥0.1 mV (≥1 mm) in at least 2 contiguous leads on the ECG, OR B. Elevation of cardiac biomarkers within 24 hours of randomization, defined as elevated troponin T, troponin I, or CK-MB level above upper limit of normal AND Planned to have a coronary angiography (followed, when indicated, by PCI) as early as possible (after at least 2 hours of treatment with study drug) and within 36 hours (at the latest on Day 3, if justified) AND Informed consent obtained in writing Exclusion Criteria:
- •Exclusion criteria related to study methodology A. General
- •High likelihood of being unavailable for the Day 180 follow up
- •Age <18 years old (or country?s legal age of majority)
- •Pregnancy, as evidenced by a positive urine pregnancy test performed prior to randomization (applicable only to women of childbearing potential, ie, women who are pre-menopausal or <2 years post-menopausal)
- •Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization, or planned use of investigational agents or devices during the study duration
- •Breastfeeding B. Cardiovascular
- •Revascularization procedure already performed for the qualifying event.
- •Acute ST-segment elevation MI C. Related to prior or concomitant treatments
- •Patient having received curative dose of anticoagulant treatment (including UFH, LMWH, or bivalirudin) for more than 24 hours prior to randomization.
- •Inability to discontinue current anticoagulation in order to transition to Investigational Products according to the specified transition timing
- •Patients who can not be treated by aspirin and clopidogrel (or any other oral antiplatelet agent) according to their local labeling
- •Exclusion criteria related to the active comparator and/or mandatory background therapies A. Related to eptifibatide
- •Patient who cannot be treated with eptifibatide according to the national labeling (when available). In countries where eptifibatide is not approved the reference label to be considered will be either the European labeling or the US labeling (see Appendix H and Appendix I). B. Related to unfractionated heparin
- •Patient who cannot be treated with unfractionated heparin according to the national labeling C. Related to otamixaban
- •Allergy to otamixaban " "Exclusion criteria related to study methodologyAny major orthopedic surgery in the 3 months prior to study start Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome Patients at high risk of bleeding Known allergy to heparin.
- •or enoxaparin Any contra-indications to the performance of venography ".
结局指标
主要结局
Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction
时间窗: from randomization (day 1) to day 7
次要结局
- "1)Triple efficacy composite of all-cause death, new myocardial infarction and any stroke from randomization (Day 1) to Day 7(2)Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction from randomization (Day 1 to Day 30))
研究者
研究点 (35)
Loading locations...
相似试验
已完成
4 期
A randomized, multicentre, double-blind, parallel, sham-controlled study of the gammaCore®, a non-invasive neurostimulator device for the acute relief of episodic and chronic cluster headache.cluster headaches10019231NL-OMON40599electroCore LLC35
已完成
3 期
A Multinational Randomized Double Blind, Placebo-controlled study to evaluate the efficacy and safety of AVE5026 in the prevention of Venous Thromembolism(VTE) in cancer patients at high risk for VTE and who are undergoing chemotherapyCTRI/2008/091/000277Sanofi Synthelabo I Ltd3,200
已完成
2 期
A randomised, controlled, double-blind trial to investigate the effects of a new infant formula on growth, tolerance and safety in healthy term infants.effect op de groei van zuigelingeneffects on growthNL-OMON39783utricia Research - Centre for Specialised Nutrition121
已完成
2 期
A randomized, double-blind, parallel group study to evaluate metabolic effects of LCZ696 and amlodipine in obese hypertensive subjects: the CLCZ696B2207 studyInsulin sensitivitymetabolism1001842410013317NL-OMON40044Medisch Universitair Ziekenhuis Maastricht28
已完成
2 期
A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis PatientsPulmonary alveolar proteinosisNL-OMON46238Savara ApS9