Pharmacoinvasive Therapy With Prourokinase
The Efficacy and Safety of Pharmacoinvasive Therapy With Prourokinase for Acute ST Segment Elevation Myocardial Infarction Patients With Expected Percutaneous Coronary Intervention Related Delay
1 other identifier
interventional
197
1 country
1
Brief Summary
The aim of this study is to elucidate the efficacy and safety of pharmacoinvasive therapy by using prourokinase (prouk), a unique fibrin-specific agent, in patients with ST-segment elevation myocardial infarction (STEMI)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 13, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedJuly 27, 2012
July 1, 2012
1 year
July 13, 2012
July 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
angiographic parameters which can demonstrate the myocardium reperfusion, including TIMI flow grade (grade I-III), TIMI frame count (frame) and myocardial blush grade (MBG,grade 0-3).
90 minutes after prourokinase bolus
Secondary Outcomes (1)
major adverse cardiac events [MACE, defined as the composite of all cause-death, reinfarction, revascularization (including target vessel and non-target vessel revascularizations), or rehospitalization due to new or worsening congestive heart failure]
12 month after enrollment
Study Arms (2)
primary PCI
PLACEBO COMPARATORprouk-PCI
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- age 75 years or younger, symptom onset 6 h or less before randomization, intention to undertake primary PCI, ST-segment elevation of 2 mm or more in two anterior leads or of 1 mm or more in two inferior leads if they had ST-segment elevation, or new left bundle-branch block.
You may not qualify if:
- expected arrival at the catheterization laboratory less than 1 h or more than 3 h after randomization, anticipated problems with vascular access, previous enrollment to other studies, and the usual contraindications to thrombolytic therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shenyang Northern Hospital
Shenyang, Liaoning, 110016, China
Related Publications (1)
Han YL, Liu JN, Jing QM, Ma YY, Jiang TM, Pu K, Zhao RP, Zhao X, Liu HW, Xu K, Wang G, Wang B, Sun RH, Wang J. The efficacy and safety of pharmacoinvasive therapy with prourokinase for acute ST-segment elevation myocardial infarction patients with expected long percutaneous coronary intervention-related delay. Cardiovasc Ther. 2013 Oct;31(5):285-90. doi: 10.1111/1755-5922.12020.
PMID: 23634911DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2012
First Posted
July 17, 2012
Study Start
November 1, 2008
Primary Completion
November 1, 2009
Study Completion
December 1, 2010
Last Updated
July 27, 2012
Record last verified: 2012-07