Efficacy and Safety on Prouk for STEMI Patients in China

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou RxD Biopharmaceutical Co., Ltd

Criteria

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;