Efficacy and Safety on Prouk for STEMI Patients in China

February 24, 2015 updated by: Suzhou RxD Biopharmaceutical Co., Ltd

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • Shenyang Northern Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yaling Han, MD, PhD
        • Sub-Investigator:
          • Geng Wang, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rhprouk
rhprouk to be administrated in 60 minutes.
Drug: rhprouk
rh-prouk will be administrated within 60 minutes after the patients eligibility confirmed
Other Names:
  • Controlled
No Intervention: controlled
The controlled arm patients will be administrated in 90 minutes after randomized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the percentage of STEMI patients achieving the recanalization of Coronary between the two arms
Time Frame: 90 minutes after administrative of active/comparator
90 minutes after administrative of active/comparator

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou RxD Biopharmaceutical Co., Ltd

Investigators

  • Study Director: Weiqun Shen, MD/PhD, Suzhou RxD Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 15, 2015

First Submitted That Met QC Criteria

February 13, 2015

First Posted (Estimate)

February 20, 2015

Study Record Updates

Last Update Posted (Estimate)

February 25, 2015

Last Update Submitted That Met QC Criteria

February 24, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012L01494

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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