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Efficacy and Safety on Prouk for STEMI Patients in China

Primary Purpose

STEMI

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
rhprouk
Sponsored by
Suzhou RxD Biopharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STEMI

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • Shenyang Northern HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

rhprouk

controlled

Arm Description

rhprouk to be administrated in 60 minutes.

The controlled arm patients will be administrated in 90 minutes after randomized.

Outcomes

Primary Outcome Measures

To compare the percentage of STEMI patients achieving the recanalization of Coronary between the two arms

Secondary Outcome Measures

Full Information

First Posted
January 15, 2015
Last Updated
February 24, 2015
Sponsor
Suzhou RxD Biopharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02367976
Brief Title
Efficacy and Safety on Prouk for STEMI Patients in China
Official Title
A Phase III Study to Research the Efficacy and Safety on Prouk for ST Elevated Mycadial Infarction Patients in China
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou RxD Biopharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rhprouk
Arm Type
Experimental
Arm Description
rhprouk to be administrated in 60 minutes.
Arm Title
controlled
Arm Type
No Intervention
Arm Description
The controlled arm patients will be administrated in 90 minutes after randomized.
Intervention Type
Drug
Intervention Name(s)
rhprouk
Other Intervention Name(s)
Controlled
Intervention Description
rh-prouk will be administrated within 60 minutes after the patients eligibility confirmed
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weiqun Shen, MD/PhD
Email
jingzhang@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Zhang, PhD
Email
jingzhang@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiqun Shen, MD/PhD
Organizational Affiliation
Suzhou RxD Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
Shenyang Northern Hospital
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiqun Shen, MD/PhD
Email
jingzhang@gmail.com
First Name & Middle Initial & Last Name & Degree
Jing Zhang, PhD
Email
jingzhang@gmail.com
First Name & Middle Initial & Last Name & Degree
Yaling Han, MD, PhD
First Name & Middle Initial & Last Name & Degree
Geng Wang, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety on Prouk for STEMI Patients in China

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