A Prospective Phase III Parallel, Randomised Controlled Trial Using Double-bolus Recombinant Staphylokinase (THR-100) vs Streptokinase in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- To demonstrate efficacy of THR100 as compared with streptokinase by assessment of 12-lead Electrocardiogram, specific cardiac Enzymes levels, pain relief and TIMI-90. (Non-Inferiority study)
研究概览
简要总结
This novel fibrinolytic agent is a 136 amino acid single chain protein secreted by some strains of Staphylococcus aureus and readily produced by recombinant DNA technology. Two natural variants of recombinant staphylokinase, THR-100 and SakSTAR, have been developed for investigational use in preliminary trials. Like SK, it forms an equimolar complex with plasmin which in turn activates plasminogen to plasmin. Unlike SK, the complexed, activated molecule (which undergoes proteolytic cleavage of the first ten amino acids to generate active staphylokinase) has a high degree of fibrin-selectivity in a human plasma milieu. This fibrin-selectivity is due in large measure to potent activation at the clot surface by trace amounts of plasmin, and rapid inactivation of the circulating complex by antiplasmin. Hence, it provides an interesting and promising alternative therapy.
详细描述
STUDY SUMMARY/PROTOCOL OUTLINE
Protocol Number: BBIL/STA/O5/2007 Protocol Name: A PROSPECTIVE PHASE III PARALLEL, RANDOMISED CONTROLLED TRIAL USING DOUBLE-BOLUS THR-100 (RECOMBINANT STAPHYLOKINASE) Vs STREPTOKINASE IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION
Drug under Study: THR-100 (Recombinant Staphylokinase)
Intended Indication: Acute Myocardial Infarction
Study Design: Randomized, Parallel Group, Multicenter and Active-Comparator Trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 30 to < 75 years inclusive.
- •Patients presenting within 12 hours with symptoms presumed secondary to an acute myocardial infarction lasting at least 20 minutes and accompanied by ECG evidence of > 1mm of ST elevation in 2 or more limb leads or > 2mm in 2 or more contiguous precordial leads or suspected new left bundle branch block will be eligible.
- •Patients must be in the hospital or the emergency department and able to receive the study medication within 12 hours of onset of symptoms.
- •Females of child-bearing age, not using a generally accepted method of contraception must have a negative urine pregnancy test.
- •Written informed consent should be sought from the patient prior to inclusion in the study. If unable to do so, informed verbal consent will be obtained. If neither is possible, a legally acceptable representative (relative) should provide written consent.
- •NB Verbal or written consent should be followed by written informed consent from the patient at the earliest subsequent opportunity.
排除标准
- •Previous administration of staphylokinase.
- •Active bleeding or known hemorrhagic diathesis.
- •Any history of stroke, transient ischemic attack, dementia, or structural CNS damage e.g. neoplasm, aneurysm, AV malformation.
- •Major surgery or trauma within the past 3 months.
- •Significant hypertension i.e. SBP 180 mm Hg and/or DBP 110 mm Hg at any time from admission to randomization.
- •Current treatment with vitamin K antagonists resulting with an INR > 1.
- •Anticipated difficulty with vascular access.
- •Prolonged (>10 min) cardiopulmonary resuscitation or cardiogenic shock.
- •Patients who have participated in an investigational drug study within the past 30 days.
- •Pregnancy or lactation, parturition within the previous 30 days.
- •Any serious concomitant systemic or life limiting disorder that would be incompatible with the trial
- •Patients known to have a history of or life limiting malignant disease or HIV.
- •Significant hepatic or renal dysfunction or any other condition which, in the opinion of the Investigator, makes the patient unsuitable for study entry.
- •Previous participation in this trial
研究组 & 干预措施
Test - THR-100
120 subjects are to be recruited into the trial, with patients randomized in a 1:1 allocation ratio to THR-100 and Streptokinase 60 subjects are to be recruited into Test arm, and administered 15 mg double-bolus (15mg/15ml), separated by 30 minutes (total 30 mg)
干预措施: THR-100 (Drug)
Streptokinase
120 subjects are to be recruited into the trial, with patients randomized in a 1:1 allocation ratio to THR-100 and Streptokinase Streptokinase: Standard regimen (1.5 million IU) is made up in 150 ml of physiological saline or glucose solution and administered intravenously over a period of 60 minutes.
干预措施: Streptokinase (Drug)
结局指标
主要结局
To demonstrate efficacy of THR100 as compared with streptokinase by assessment of 12-lead Electrocardiogram, specific cardiac Enzymes levels, pain relief and TIMI-90. (Non-Inferiority study)
时间窗: up to 4 weeks
12-lead Electrocardiogram, ≥50% resolution of ST segment in single ECG lead of maximum deviation present at 90 minutes and 24 hours after start of thrombolytic therapy.
次要结局
- To evaluate the safety profile of THR-100 in comparison with Streptokinase(up to 4 weeks)