Completed

Intravenous Streptokinase in Acute Myocardial Infarction

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What is being tested

streptokinase

Drug
Who is being recruted

Cardiovascular Diseases
+2

+ Coronary Disease
+ Heart Diseases
From 18 to 74 Years
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 1983

Summary

Principal SponsorUniversity of Washington
Last updated: February 10, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 1983Actual date on which the first participant was enrolled.

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

Official TitleIntravenous Streptokinase in Acute Myocardial Infarction 
Principal SponsorUniversity of Washington
Last updated: February 10, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 74 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Criteria
No eligibility criteria are available at this time.Please check with the study contact for more details. 
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Study Centers

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CompletedNo study centers
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