Intravenous Streptokinase in Acute Myocardial Infarction

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000507
• Other study ID #: 26
• Secondary ID: R01HL030300
• Status: Completed
• Phase: Phase 3
• First received: October 27, 1999
• Last updated: February 8, 2016
• Start date: August 1983
• Est. completion date: October 1994

Study information

• Verified date: October 1994
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

To determine whether the administration of intravenous streptokinase (SK) early in the course of acute, transmural myocardial infarction would limit myocardial damage.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 1994
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years
• Eligibility: Men and women, aged less than 75. Myocardial infarction onset within six hours.

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Drug:
• streptokinase

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (3)

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. Erratum in: Circulation 1988 May;77(5):1037. — View 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. — View 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. — View Citation