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Pharmacoinvasive Therapy With Prourokinase

Primary Purpose

ST-segment Elevation Myocardial Infarction (STEMI)

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Prourokinase
Placebo
Sponsored by
Suzhou Landing Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction (STEMI)

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Shenyang Northern Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

primary PCI

prouk-PCI

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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]

Full Information

First Posted
July 13, 2012
Last Updated
July 26, 2012
Sponsor
Suzhou Landing Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01642667
Brief Title
Pharmacoinvasive Therapy With Prourokinase
Official Title
The Efficacy and Safety of Pharmacoinvasive Therapy With Prourokinase for Acute ST Segment Elevation Myocardial Infarction Patients With Expected Percutaneous Coronary Intervention Related Delay
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Landing Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-segment Elevation Myocardial Infarction (STEMI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
primary PCI
Arm Type
Placebo Comparator
Arm Title
prouk-PCI
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Prourokinase
Intervention Description
a bolus of 1.2 million IU and an infusion of 4.8 million IU in 60 min.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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).
Time Frame
90 minutes after prourokinase bolus
Secondary Outcome Measure Information:
Title
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]
Time Frame
12 month after enrollment

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Shenyang Northern Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23634911
Citation
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.
Results Reference
derived

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Pharmacoinvasive Therapy With Prourokinase

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