Clinical trial NCT02367976: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: STEMI
Lead sponsor: Suzhou RxD Biopharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2015-02-20
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: To compare the percentage of STEMI patients achieving the recanalization of Coronary between the two arms
timeFrame: 90 minutes after administrative of active/comparator
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shenyang Northern Hospital
state: Liaoning
Study officials:
affiliation: Suzhou RxD Biopharma
name: Weiqun Shen, MD/PhD
role: STUDY_DIRECTOR
References: