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

Phase 3

Completed

• Conditions: Prosthetic Valve Thrombosis
• Interventions: Drug: Streptokinase

• Registration Number: NCT00232622
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-10-03
• Study First Submitted QC: 2005-10-03
• Study First Posted: 2005-10-05
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-23
• Last Update Posted: 2013-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard infusion of streptokinase	Streptokinase	Standard infusion of streptokinase
Accelerated infusion of streptokinase	Streptokinase	Accelerated infusion of streptokinase

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Death, Major bleeding and minor bleeding	In-hospital