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Pharmacoinvasive Therapy With Prourokinase

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Suzhou Landing Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01642667
First received: July 13, 2012
Last updated: July 26, 2012
Last verified: July 2012

July 13, 2012
July 26, 2012
November 2008
November 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
angiographic parameters which can demonstrate the myocardium reperfusion [ Time Frame: 90 minutes after prourokinase bolus ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01642667 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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)

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
ST-segment Elevation Myocardial Infarction (STEMI)
  • Drug: Prourokinase
    a bolus of 1.2 million IU and an infusion of 4.8 million IU in 60 min.
  • Drug: Placebo
  • Placebo Comparator: primary PCI
    Intervention: Drug: Placebo
  • Active Comparator: prouk-PCI
    Intervention: Drug: Prourokinase
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
197
December 2010
November 2009   (final data collection date for primary outcome measure)

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.
Both
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01642667
PROUK
Yes
Suzhou Landing Pharmaceuticals
Suzhou Landing Pharmaceuticals
Not Provided
Not Provided
Suzhou Landing Pharmaceuticals
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP