Trial | NCT02367976  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Indication/Condition

    STEMI

  • Intervention/Treatment

    alteplase ...

  • Study Participants

    450
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.
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 Started
Jan 31
2015
Primary Completion
Dec 31
2016
Anticipated
Study Completion
Dec 31
2017
Anticipated
Last Update
Feb 25
2015
Estimate

Drug rhprouk

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

  • Other names: Controlled

rhprouk Experimental

rhprouk to be administrated in 60 minutes.

controlled No Intervention

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

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;
No Results Posted