Intravenous Streptokinase in Acute Myocardial Infarction
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Heart Diseases
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
streptokinase
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Diseases
Eligibility Criteria
Men and women, aged less than 75. Myocardial infarction onset within six hours.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000507
First Posted
October 27, 1999
Last Updated
February 8, 2016
Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000507
Brief Title
Intravenous Streptokinase in Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
October 1994
Overall Recruitment Status
Completed
Study Start Date
August 1983 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 1994 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To determine whether the administration of intravenous streptokinase (SK) early in the course of acute, transmural myocardial infarction would limit myocardial damage.
Detailed Description
BACKGROUND:
Determination of the potential value of thrombolytic therapy in patients with acute myocardial infarction was an issue of major importance in 1983. An estimated 1.4 million heart attacks occurred each year, of which over 500,000 were fatal. Reduction of mortality required an effective means to reduce infarct size. Studies indicated that reperfusion represented a potent means of achieving salvage of ischemic myocardium. Pilot clinical studies indicated that reperfusion could be achieved in a substantial percentage of patients by lysis of coronary thrombosis with both intracoronary and intravenous streptokinase administration. Intracoronary thrombolysis was receiving widespread clinical applications but had many limitations. The intracoronary route took 90-120 minutes longer to administer than the intravenous route. Because intracoronary therapy required the availability of a catheterization laboratories and highly skilled invasive cardiologists, this treatment was not available to large numbers of patients who were hospitalized in smaller community hospitals.
DESIGN NARRATIVE:
Randomized design with two groups and fixed sample size. Control patients received routine coronary care. The treatment group received intravenous streptokinase plus conventional care. This was followed with intravenous heparin and warfarin. The primary endpoint was 14 day mortality. Secondary endpoints included angiographic patency of the involved coronary artery at 10 to 14 days, left ventricular function, segmental wall motion analysis, and myocardial infarction size at 30-45 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
streptokinase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Men and women, aged less than 75. Myocardial infarction onset within six hours.
12. IPD Sharing Statement
Citations:
PubMed Identifier
3396164
Citation
Martin GV, Sheehan FH, Stadius M, Maynard C, Davis KB, Ritchie JL, Kennedy JW. Intravenous streptokinase for acute myocardial infarction. Effects on global and regional systolic function. Circulation. 1988 Aug;78(2):258-66. doi: 10.1161/01.cir.78.2.258.
Results Reference
background
PubMed Identifier
3280640
Citation
Ritchie JL, Cerqueira M, Maynard C, Davis K, Kennedy JW. Ventricular function and infarct size: the Western Washington Intravenous Streptokinase in Myocardial Infarction Trial. J Am Coll Cardiol. 1988 Apr;11(4):689-97. doi: 10.1016/0735-1097(88)90197-0.
Results Reference
background
PubMed Identifier
3276409
Citation
Kennedy JW, Martin GV, Davis KB, Maynard C, Stadius M, Sheehan FH, Ritchie JL. The Western Washington Intravenous Streptokinase in Acute Myocardial Infarction Randomized Trial. Circulation. 1988 Feb;77(2):345-52. doi: 10.1161/01.cir.77.2.345. Erratum In: Circulation 1988 May;77(5):1037.
Results Reference
background
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Intravenous Streptokinase in Acute Myocardial Infarction
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