NCT00079508已完成3 期
A Phase III Study of Angiomax (Bivalirudin) in Patients With HIT/HITTS Type II Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Primary Endpoint
研究概览
简要总结
The purpose of this study is to demonstrate that in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) Type II undergoing cardiac surgery on cardiopulmonary bypass (CPB), Angiomax is a safe and effective anticoagulant.
详细描述
An open-label, prospective, multicenter, single-arm study; with a historical reference cohort of similarly identified HIT/HITTS patients from participating institutions that underwent cardiac surgery on CPB with alternative anticoagulation regimens during the period of approximately 12 months prior to initiation of the first patient into this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent before initiation of any study-related procedures, and
- •Be at least 18 years of age, and
- •Be scheduled for CABG, CABG single valve surgery, or isolated single valve surgery on CPB. Patients undergoing repeat (redo) CABG are also considered eligible for this study, and demonstrated
- •New diagnosis or history of objectively documented HIT/HITTS Type II, defined as one or more of the following:
- •Positive heparin-induced platelet aggregation (HIPA) or other functional assay for HIT or immunoassay for HIT antibodies (ELISA), AND/OR
- •HIT: Thrombocytopenia associated with heparin therapy, where the platelet count has decreased by 50%*, OR
- •HITTS: Thrombocytopenia (as defined in B above) PLUS any evidence of arterial or venous thrombosis
排除标准
- •Confirmed pregnancy at time of enrollment via IVRS (if woman of child-bearing potential) (Urine or serum pregnancy test)
- •Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
- •Intracranial neoplasm, arteriovenous malformation or aneurysm.
- •Dependency on renal dialysis or creatinine clearance <30mL/min.
- •Ongoing treatment with warfarin (or other oral anticoagulant) at the time of enrollment.
- •Patients previously treated with warfarin may be enrolled if warfarin therapy can be safely discontinued and baseline INR is < 1.3 times control in the absence of heparin therapy.
- •Known allergy to Angiomax or hirudin derived drugs, or known sensitivity to any component of the product.
- •Patients receiving clopidogrel (Plavix®) within the previous 5 days may be enrolled if in the opinion of the Investigator the benefits of surgery outweigh the risk associated with recent clopidogrel administration.
- •Patients receiving a glycoprotein IIb/IIIa inhibitor within the previous 48 hours prior to enrollment if abciximab (ReoPro®) or 12 hours if eptifibatide (Integrilin®) or tirofiban (Aggrastat®), may be enrolled if in the opinion of the Investigator the benefits of surgery outweigh the risk associated with not waiting the 48 or 12 hour time period prior to enrollment.
- •Patients receiving lepirudin (Refludan®) or argatroban within the previous 24 hours prior to enrollment.
- •Patients currently receiving lepirudin or argatroban can be enrolled if they are switched to Angiomax at least 24 hours prior to the planned cardiac surgery.
- •Patients receiving LMWH or thrombolytics within the previous 12 hours may be enrolled if in the opinion of the Investigator the benefits of surgery outweigh the risk associated with not waiting the 12 hour time period.
- •Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.
- •Refusal to undergo blood transfusion should it become necessary.
- •Any other disease or condition, which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial.
- •Planned surgical procedure in which proximal anastomoses will precede distal anastomoses of the bypass grafts.
- •Planned (>1) double (or greater) valve repair-replacement (e.g.: AVR-MVR) surgery.
结局指标
主要结局
Primary Endpoint
时间窗: 7 days
In-hospital acute procedural success, defined as the absence of death, Q wave MI, repeat coronary revascularization, and stroke (hemorrhagic or ischemic) at hospital discharge or Day 7 after surgery ('Day 7/discharge'), whichever occurs first.
次要结局
未报告次要终点
研究者
研究点 (1)
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