NCT00073580已完成3 期
Angiomax in Patients With HIT/HITTS Type II Undergoing Off-PUMP CABG
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Primary Endpoint
研究概览
简要总结
The purpose of this study is to examine the safety and efficacy of Angiomax as an anticoagulation in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia with thrombosis syndrome (HITTS) undergoing off-pump coronary artery bypass (OPCAB) surgery.
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
- 未提供
排除标准
- •Confirmed pregnancy, by urine or serum pregnancy test (if woman of child-bearing potential).
- •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 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 contemplated OPCAB.
- •Patients receiving low molecular weight heparin (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 randomization.
- •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 inability to comply with study requirements.
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 myocardial infarction (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 (2)
Loading locations...
相似试验
已完成
3 期
Angiomax in Patients With HIT/HITTS Type II Undergoing CPBCoronary Artery Bypass SurgeryCardiovascular DiseaseNCT00079508The Medicines Company125
终止
4 期
Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary InterventionCoronary Artery DiseaseNCT01464671Stony Brook University260
已完成
3 期
Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCABCardiac SurgeryCoronary Artery Bypass SurgeryNCT00073593The Medicines Company150
已完成
1 期
Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer (Phase1/2)Pancreatic CancerNCT00655785Fukushima Medical University17
已完成
1 期
Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot StudySeptic ShockNCT01393782George Washington University20