Efficacy and Safety on Prouk for STEMI Patients in China
NCT ID: NCT02367976
Last Updated: 2015-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
450 participants
INTERVENTIONAL
2015-01-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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rhprouk
rhprouk to be administrated in 60 minutes.
rhprouk
rh-prouk will be administrated within 60 minutes after the patients eligibility confirmed
controlled
The controlled arm patients will be administrated in 90 minutes after randomized.
No interventions assigned to this group
Interventions
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rhprouk
rh-prouk will be administrated within 60 minutes after the patients eligibility confirmed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
18 Years
75 Years
ALL
No
Sponsors
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Suzhou RxD Biopharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Weiqun Shen, MD/PhD
Role: STUDY_DIRECTOR
Suzhou RxD Biopharma
Locations
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Shenyang Northern Hospital
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2012L01494
Identifier Type: -
Identifier Source: org_study_id
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