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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Ganesan Karthikeyan, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00232622
First received: October 3, 2005
Last updated: October 23, 2013
Last verified: October 2013

October 3, 2005
October 23, 2013
November 2004
March 2007   (final data collection date for primary outcome measure)
The occurrence of a complete clinical response (complete hemodynamic response as assessed by echocardiography and fluoroscopy, without any major complication) [ Time Frame: In-hospital ] [ Designated as safety issue: No ]
The occurrence of a complete clinical response (complete hemodynamic response as assessed by echocardiography and fluoroscopy, without any major complication)
Complete list of historical versions of study NCT00232622 on ClinicalTrials.gov Archive Site
Death, Major bleeding and minor bleeding [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]
Death, Major bleeding and minor bleeding
Not Provided
Not Provided
 
A Study Comparing a New Dosing Regimen of Clot-dissolving Drug for Mechanical Heart Valves Which Show Clots
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prosthetic Valve Thrombosis
  • Drug: Streptokinase
    Accelerated infusion of streptokinase
    Other Name: Fibrinolytic therapy
  • Drug: Streptokinase
    Standard dose streptokinase
    Other Name: Fibrinolytic therapy
  • Active Comparator: Standard infusion of streptokinase
    Standard infusion of streptokinase
    Intervention: Drug: Streptokinase
  • Experimental: Accelerated infusion of streptokinase
    Accelerated infusion of streptokinase
    Intervention: Drug: Streptokinase

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
12 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00232622
A-29/3.3.2004
No
Dr Ganesan Karthikeyan, All India Institute of Medical Sciences, New Delhi
All India Institute of Medical Sciences, New Delhi
Not Provided
Principal Investigator: Ganesan Karthikeyan, MD, DM Department of Cardiology, All India Institute of Medical Sciences
All India Institute of Medical Sciences, New Delhi
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP