Efficacy and Safety on Prouk for STEMI Patients in China

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy and safety of rh-prouk as pharmacoinvasive therapy on those ST Elevated Myocardial Infarctions patients, it is designed as a multicenter, active controlled, single blinded study. The primary endpoint is to assess the coronary recanalization 90 minutes after thrombolysis. The secondary endpoint is to evaluate the mortality rate at day 30.

Detailed Description
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The purpose of the study is to evaluate the efficacy and safety of rh-prouk as pharmacoinvasive therapy on those ST Elevated Myocardial Infarctions patients, it is designed as a multicenter, active controlled, single blinded study. The primary endpoint is to assess percentage of patients achieve the coronary recanalization 90 minutes after thrombolysis. The secondary endpoint is to evaluate the mortality rate at day 30.

Official Title
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A Phase III Study to Research the Efficacy and Safety on Prouk for ST Elevated Mycadial Infarction Patients in China

Conditions
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STEMI

Intervention / Treatment
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* Drug: rhprouk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chest pain > 30 minutes, while <12 hours Expected PCI related delayed time > 60 minutes, OR Door To Balloon time >90 minutes ECG confirmed STEMI. Age: 18--75 years old Weight <=85Kg Consent to participate in this study Exclusion Criteria Evidence of cardiac rupture; ECG: new left bundle branch block; Thrombolysis contradictions Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e. < 3 months); Active bleeding or known bleeding disorder. Recent administration of any i.v. or s.c. anticoagulation within 12 hours includingunfractionated heparin, enoxaparin and/or bivalirudin or current use of oral anticoagulation(warfarin or coumadin); Uncontrolled hypertension, defined as a single blood pressure measurement ≥ 180/110 mm Hg (systolic BP ≥ 180 mm Hg and/or diastolic BP ≥ 110 mm Hg) prior to randomisation; Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current myocardial infarction); Prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) within the past 2 Weeks Major surgery pending in the following 30 days;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rhprouk<br>rhprouk to be administrated in 60 minutes. | Drug: rhprouk<br>* rh-prouk will be administrated within 60 minutes after the patients eligibility confirmed<br>* Other names: Controlled;|
| No Intervention: controlled<br>The controlled arm patients will be administrated in 90 minutes after randomized. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the percentage of STEMI patients achieving the recanalization of Coronary between the two arms |  | 90 minutes after administrative of active/comparator |