Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232622
Status:
COMPLETED
Last Update Posted:
2013-10-24
First Post:
2005-10-03
Brief Title:
A Study Comparing a New Dosing Regimen of Clot-dissolving Drug for Mechanical Heart Valves Which Show Clots
Sponsor:
All India Institute of Medical Sciences New Delhi
Organization:
All India Institute of Medical Sciences New Delhi
Study Overview
Official Title:
A Prospective Randomized Trial of a Rapid Fibrinolytic Protocol for Left-sided Prosthetic Valve Thrombosis
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAFT-PVT
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 15 MU of SK is given over 1 hour followed if required by a 01 MUh infusion In the standard protocol SP 025 MU is given over 30 minutes followed by an infusion of 01 MUh 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 α005
This is a prospective randomized trial comparing 2 fibrinolytic protocols in a first episode of PVT In the rapid fibrinolytic protocol RFP 15 MU of SK is given over 1 hour followed if required by a 01 MUh infusion In the standard protocol SP 025 MU is given over 30 minutes followed by an infusion of 01 MUh 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 α005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None