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Pharmacoinvasive Therapy With Prourokinase

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ClinicalTrials.gov Identifier: NCT01642667
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : July 27, 2012
Sponsor:
Information provided by (Responsible Party):
Suzhou Landing Pharmaceuticals

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)

Condition or disease Intervention/treatment Phase
ST-segment Elevation Myocardial Infarction (STEMI) Drug: Prourokinase Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Placebo Comparator: primary PCI Drug: Placebo
Active Comparator: prouk-PCI Drug: Prourokinase
a bolus of 1.2 million IU and an infusion of 4.8 million IU in 60 min.




Primary Outcome Measures :
  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). [ Time Frame: 90 minutes after prourokinase bolus ]

Secondary Outcome Measures :
  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] [ Time Frame: 12 month after enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01642667


Locations
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China, Liaoning
Shenyang Northern Hospital
Shenyang, Liaoning, China, 110016
Sponsors and Collaborators
Suzhou Landing Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Suzhou Landing Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01642667    
Other Study ID Numbers: PROUK
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: July 27, 2012
Last Verified: July 2012
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Saruplase
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action