Efficacy and Safety on Prouk for STEMI Patients in China

Phase 3

• Conditions: STEMI
• Interventions: Drug: rhprouk

• Registration Number: NCT02367976
• Lead Sponsor: Suzhou RxD Biopharmaceutical Co., Ltd

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-15
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-20
• Last Update Submitted: 2015-02-24
• Last Update Posted: 2015-02-25
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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;

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rhprouk	rhprouk	rhprouk to be administrated in 60 minutes.

Primary Outcome Measures

Name	Time	Method
To compare the percentage of STEMI patients achieving the recanalization of Coronary between the two arms	90 minutes after administrative of active/comparator

Trial Locations

Locations (1)

Shenyang Northern Hospital; 🇨🇳 Shenyang, Liaoning, China