Prosthetic Valve Thrombosis Clinical Trial
Official title:
A Prospective Randomized Trial of a Rapid Fibrinolytic Protocol for Left-sided Prosthetic Valve Thrombosis
The optimal dosage and duration of administration of clot-dissolving medications for the treatment of patients with mechanical heart valves with clots is not known. We hypothesized that a large dose of the clot-dissolving medicine given initially (akin to the dose given in the treatment of heart attacks), might speed up the dissolution of the clot and rapidly restore the functioning of the mechanical heart valve.
The optimal fibrinolytic strategy for left sided prosthetic valve thrombosis (PVT) is not
known. A large initial bolus dose of streptokinase (SK) might accelerate fibrinolysis and
restore valve function more rapidly.
This is a prospective, randomized trial comparing 2 fibrinolytic protocols in a first
episode of PVT. In the rapid fibrinolytic protocol (RFP) 1.5 MU of SK is given over 1 hour,
followed if required by a 0.1 MU/h infusion. In the standard protocol (SP) 0.25 MU is given
over 30 minutes, followed by an infusion of 0.1 MU/h. Serial echocardiography and
fluoroscopy will be done to monitor therapy. The primary end point is the occurrence of a
complete clinical response (CCR, complete hemodynamic response without any major
complication). 58 patients are required in each arm for detecting a 30% difference with 80%
power at α=0.05.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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