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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
  Purpose

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 Intervention Phase
ST-segment Elevation Myocardial Infarction (STEMI)
Drug: Prourokinase
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Suzhou Landing Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 197
Study Start Date: November 2008
Study Completion Date: December 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642667

Locations
China, Liaoning
Shenyang Northern Hospital
Shenyang, Liaoning, China, 110016
Sponsors and Collaborators
Suzhou Landing Pharmaceuticals
  More Information

No publications provided by Suzhou Landing Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Suzhou Landing Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01642667     History of Changes
Other Study ID Numbers: PROUK
Study First Received: July 13, 2012
Last Updated: July 26, 2012
Health Authority: P.R China:Ministry of Health P.R China

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Saruplase
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014