Efficacy and Safety on Prouk for STEMI Patients in China

Suzhou RxD Biopharmaceutical

Status and phase

Unknown

Phase 3

Conditions

STEMI

Treatments

Drug: rhprouk

Study type

Interventional

Funder types

Industry

Identifiers

NCT02367976

2012L01494

Details and patient eligibility

About

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.

Full 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.

Enrollment

450 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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;