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Intravenous Streptokinase in Acute Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT00000507
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : February 10, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Washington

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

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Infarction Myocardial Ischemia Drug: streptokinase Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : August 1983
Estimated Study Completion Date : October 1994

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women, aged less than 75. Myocardial infarction onset within six hours.

Publications:
ClinicalTrials.gov Identifier: NCT00000507     History of Changes
Other Study ID Numbers: 26
R01HL030300 ( U.S. NIH Grant/Contract )
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: October 1994

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Ischemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Pathologic Processes
Necrosis
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Streptokinase
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action