Intravenous Streptokinase in Acute Myocardial Infarction

NCT ID: NCT00000507

Last Updated: 2016-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1983-08-31
• Study Completion Date: 1994-10-31

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.

Conditions

Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

streptokinase

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Men and women, aged less than 75. Myocardial infarction onset within six hours.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

References

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.

Reference Type: BACKGROUND

PMID: 3396164 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3280640 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3276409 (View on PubMed)

Other Identifiers

R01HL030300

Identifier Type: NIH

Identifier Source: secondary_id

View Link

26

Identifier Type: -

Identifier Source: org_study_id