Pharmacoinvasive Therapy With Prourokinase
Phase 2
Completed
- Conditions
- ST-segment Elevation Myocardial Infarction (STEMI)
- Interventions
- Drug: Placebo
- Registration Number
- NCT01642667
- Lead Sponsor
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description primary PCI Placebo - prouk-PCI Prourokinase -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Shenyang Northern Hospital
🇨🇳Shenyang, Liaoning, China