NL-OMON40245已完成3 期
A RANDOMIZED, OPEN-LABEL, MULTI-CENTER, ACTIVE-CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE EFFICACY AND SAFETY OF THE REG1 ANTICOAGULATION SYSTEM COMPARED TO BIVALIRUDIN IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION - REG1-CLIN310
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 405
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
- •1. The study population will consist of patients with CAD undergoing PCI. Three key subgroups will be included as follows:
- •a. Subgroup A: Patients with ischemic symptoms at rest and positive cardiac biomarkers (troponin I or T or creatine kinase-MB) related to an acute coronary syndrome event within 7 days;
- •b. Subgroup B: Patients not meeting criteria for Subgroup A with at least one of the following risk factors:
- •* Current presentation with an acute coronary syndrome
- •with positive cardiac biomarkers > 7 days prior to randomization
- •* Current presentation with unstable angina (ACS without positive
- •cardiac biomarkers)
- •* Age >70 years
- •* Diabetes
- •* Chronic kidney disease (estimated CrCl < 60 mL/min)
- •* Planned multivessel PCI
- •* Prior CABG surgery
- •* Peripheral vascular disease;
- •c. Subgroup C: Patients with negative cardiac biomarkers and no risk factor, thereby not meeting criteria for Subgroup A or B;
- •2. Willing and able to sign an Institutional Review Board/Ethics Committee (IRB/EC) approved informed consent prior to any study-related activities;
- •3. Male or female age 18 or greater;
- •4. If female of childbearing potential, must have a negative urine or serum pregnancy test or be post-menopausal for at least 1 year prior to randomization. Females of childbearing potential and males with partners of childbearing potential must
- •be using effective contraception to be eligible. Women who are nursing or lactating should not nurse while in the study as
- •the effects of this drug on nursing has not been studied. It is the Investigator*s responsibility for determining whether the patient is
- •using effective contraception and refraining from nursing for study participation;
- •5. Subject is able and willing to comply with the protocol and all study procedures,
- •including but not limited to the 20 + 4 hour blood draw, Endpoint (Day 3 +7), End-of-Study (Day 30), and 6-month vital status assessments.
排除标准
- •1. Acute ST-segment elevation myocardial infarction within 48 hours of randomization; of the following:
- •2. Evidence of current clinical instability including the following:
- •a. Sustained systolic blood pressure <90 mm Hg or cardiogenic shock;
- •b. Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade;
- •c. Suspected dissecting aortic aneurysm;
- •3. Evidence of a contraindication to anticoagulation or increased risk of bleeding such as:
- •a. Any evidence or history of intracranial bleeding or intracranial aneurysm;
- •b. Known hypercoagulable state, including treatment for malignancy (excluding basal cell skin carcinoma) in the past year, or coagulopathy with abnormal bleeding tendency;
- •c. History of intraocular hemorrhage other than due to diabetic retinopathy;
- •d. History of thrombocytopenia associated with abnormal bleeding;
- •e. History of thrombocytosis associated with a thrombotic event;
- •f. Severe trauma, fracture, major surgery, or biopsy of a parenchymal organ within 3 months;
- •g. Prolonged cardiopulmonary resuscitation within 3 months;
- •h. Major gastrointestinal bleeding within 3 months;
- •i. Spontaneous genitourinary bleeding within 3 months;
- •j. Any planned additional invasive procedure within 30 days after randomization;
- •4. Use of any investigational drug or device within 30 days of randomization or the planned use of an investigational drug or device through EOS (Day 30 follow-up);
- •5. Use of the following antithrombotic agents:
- •a. Fibrinolytic agents within 48 hours;
- •b. GP IIb/IIIa inhibitors within 24 hours;
- •c. Bivalirudin within 24 hours
- •d. Prior exposure to any component of REG1;
- •6. Baseline hemoglobin (Hgb) <9 g/dL or equivalent;
- •7. Renal impairment as determined by any one of the following:
- •a. Baseline estimated glomerular filtration rate (GFR) * 10 mL/min/1.73m²;
- •b. Currently undergoing renal replacement therapy (hemodialysis or peritoneal dialysis);
- •c. Degree of renal impairment for which use of bivalirudin is prohibited or contraindicated per local label instructions;
- •8. Baseline platelet count <100,000/mm3
- •9. Known allergy or intolerance to aspirin, to all available ADP/P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor), or to bivalirudin or REG1 (or any of their respective components); ;
- •10. The following planned procedures:
- •a. Planned staged PCI procedure within 30 days after randomization;
- •b. Planned CABG or valve surgery within 30 days after randomization;
- •11. Any other medical or psychiatric condition that in the Investigator*s judgment precludes participation in the study.
研究者
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