A Study Comparing a New Dosing Regimen of Clot-dissolving Drug for Mechanical Heart Valves Which Show Clots

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Prospective Randomized Trial of a Rapid Fibrinolytic Protocol for Left-sided Prosthetic Valve Thrombosis

Conditions
-----------------
Prosthetic Valve Thrombosis

Intervention / Treatment
-----------------
* Drug: Streptokinase
* Drug: Streptokinase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First episode of left sided prosthetic valve thrombosis Exclusion Criteria: Contraindication to thrombolysis Refusal to give informed consent Pregnant women age less than 12 years or more than 70 years previous treatment for prosthetic valve thrombosis

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard infusion of streptokinase<br>Standard infusion of streptokinase | Drug: Streptokinase<br>* Standard dose streptokinase<br>* Other names: Fibrinolytic therapy;|
| Experimental: Accelerated infusion of streptokinase<br>Accelerated infusion of streptokinase | Drug: Streptokinase<br>* Accelerated infusion of streptokinase<br>* Other names: Fibrinolytic therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of a complete clinical response (complete hemodynamic response as assessed by echocardiography and fluoroscopy, without any major complication) |  | In-hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death, Major bleeding and minor bleeding |  | In-hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prosthetic valve thrombosis, Fibrinolysis, Streptokinase