Efficacy and Safety on Prouk for STEMI Patients in China

STEMI Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02367976
• Other study ID #: 2012L01494
• Status: Recruiting
• Phase: Phase 3
• First received: January 15, 2015
• Last updated: February 24, 2015
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: February 2015
• Source: Suzhou RxD Biopharmaceutical Co., Ltd
• Contact: Weiqun Shen, MD/PhD
• Email: jingzhang[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• STEMI

Intervention

Drug:
• rhprouk
rh-prouk will be administrated within 60 minutes after the patients eligibility confirmed

Locations

Country	Name	City	State
China	Shenyang Northern Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou RxD Biopharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the percentage of STEMI patients achieving the recanalization of Coronary between the two arms		90 minutes after administrative of active/comparator	No