Efficacy and Safety on Prouk for STEMI Patients in China

NCT02367976 | Unknown Phase 3

• 1 other identifier: 2012L01494
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

STEMI

Outcome Measures

Primary Outcomes (1)

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

  90 minutes after administrative of active/comparator

Study Arms (2)

rhprouk

EXPERIMENTAL

rhprouk to be administrated in 60 minutes.

Drug: rhprouk

controlled

NO INTERVENTION

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

Interventions

rhprouk DRUG

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

Also known as: Controlled

rhprouk

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Suzhou RxD Biopharmaceutical Co., Ltd: lead

Study Sites (1)

Shenyang Northern Hospital

Shenyang, Liaoning, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Weiqun Shen, MD/PhD

  Suzhou RxD Biopharma

  STUDY DIRECTOR

Central Study Contacts

Weiqun Shen, MD/PhD

CONTACT

jingzhang@gmail.com

Jing Zhang, PhD

CONTACT

jingzhang@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: February 20, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: February 25, 2015

Record last verified: 2015-02

Locations

CN (1)