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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 13, 2012
Last Updated Date	July 26, 2012
Start Date ^ICMJE	November 2008
Primary Completion Date	November 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 26, 2012)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: July 16, 2012)	angiographic parameters which can demonstrate the myocardium reperfusion [ Time Frame: 90 minutes after prourokinase bolus ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01642667 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 16, 2012)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pharmacoinvasive Therapy With Prourokinase
Official Title ^ICMJE	The Efficacy and Safety of Pharmacoinvasive Therapy With Prourokinase for Acute ST Segment Elevation Myocardial Infarction Patients With Expected Percutaneous Coronary Intervention Related Delay
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)
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	ST-segment Elevation Myocardial Infarction (STEMI)
Intervention ^ICMJE	Drug: Prourokinase a bolus of 1.2 million IU and an infusion of 4.8 million IU in 60 min. Drug: Placebo
Study Arm (s)	Placebo Comparator: primary PCI Intervention: Drug: Placebo Active Comparator: prouk-PCI Intervention: Drug: Prourokinase
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	197
Completion Date	December 2010
Primary Completion Date	November 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	up to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01642667
Other Study ID Numbers ^ICMJE	PROUK
Has Data Monitoring Committee	Yes
Responsible Party	Suzhou Landing Pharmaceuticals
Study Sponsor ^ICMJE	Suzhou Landing Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Suzhou Landing Pharmaceuticals
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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