Efficacy and Safety on Prouk for STEMI Patients in China

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02367976

Enrollment

450

Registered

2015-02-20

Start date

2015-01-31

Completion date

2017-12-31

Last updated

2015-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

STEMI

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.

Interventions

DRUGrhprouk

rh-prouk will be administrated within 60 minutes after the patients eligibility confirmed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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;

Design outcomes

Primary

Measure	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

Countries

China

Contacts

Primary ContactWeiqun Shen, MD/PhD

jingzhang@gmail.com

Backup ContactJing Zhang, PhD