Pharmacoinvasive Therapy With Prourokinase

ST-segment Elevation Myocardial Infarction (STEMI) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642667
• Other study ID #: PROUK
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 13, 2012
• Last updated: July 26, 2012
• Start date: November 2008
• Est. completion date: December 2010

Study information

• Verified date: July 2012
• Source: Suzhou Landing Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: P.R China:Ministry of Health P.R China
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: December 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-segment Elevation Myocardial Infarction (STEMI)

Intervention

Drug:
• Prourokinase
a bolus of 1.2 million IU and an infusion of 4.8 million IU in 60 min.
• Placebo

Locations

Country	Name	City	State
China	Shenyang Northern Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Landing Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes