A Prospective Phase III Parallel, randomised controlled trial using double-bolus recombinant staphylokinase (THR-100) vs streptokinase in patients with acute myocardial infarction - recombinant staphylokinase

Bharat Biotech International Limited0 个研究点目标入组 120 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Male or female patients aged 30 to < 75 years inclusive.
•2.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 pericordial leads or suspected new left bundle branch block will be eligible.
•3.Patients must be in the hospital or the emergency department and able to receive the study medication within 12 hours of onset of symptoms as defined in (ii).
•4.Females of child-bearing age, not using a generally accepted method of contraception must have a negative urine pregnancy test.
•5.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.

•1.Previous administration of staphylokinase.
•2.Active bleeding or known hemorrhagic diathesis.
•3.Any history of stroke, transient ischemic attack, dementia, or structural CNS damage e.g. neoplasm, aneurysm, AV malformation.
•4.Major surgery or trauma within the past 3 months.
•5.Significant hypertension i.e. SBP less than or equal to 180 mm Hg and/or DBP less than or equal to 110 mm Hg at any time from admission to randomization.
•6.Current treatment with vitamin K antagonists resulting with an INR > 1.5.
•7.Anticipated difficulty with vascular access.
•8.Prolonged ( >10 min) cardiopulmonary resuscitation or cardiogenic shock.
•9.Patients who have participated in an investigational drug study within the past 30 days.
•10.Pregnancy or lactation, parturition within the previous 30 days.
•11.Any serious concomitant systemic or life limiting disorder that would be incompatible with the trial
•12.Patients known to have a history of or life limiting malignant disease or HIV.
•13.Significant hepatic or renal dysfunction or any other condition which, in the opinion of the Investigator, makes the patient unsuitable for study entry.
•14.Previous participation in this trial

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