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RAFT-PVT: 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 (Other)
Overall Status
Completed
CT.gov ID
NCT00232622
Collaborator
(none)
120
Enrollment
2
Arms
27.9
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective Randomized Trial of a Rapid Fibrinolytic Protocol for Left-sided Prosthetic Valve Thrombosis
Study Start Date :
Nov 1, 2004
Actual Primary Completion Date :
Mar 1, 2007
Actual Study Completion Date :
Mar 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard infusion of streptokinase

Standard infusion of streptokinase

Drug: Streptokinase
Standard dose streptokinase
Other Names:
  • Fibrinolytic therapy

    		•
    Experimental: Accelerated infusion of streptokinase

    Accelerated infusion of streptokinase

    Drug: Streptokinase
    Accelerated infusion of streptokinase
    Other Names:
  • Fibrinolytic therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Death, Major bleeding and minor bleeding [In-hospital]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • All India Institute of Medical Sciences, New Delhi

    Investigators

    • Principal Investigator: Ganesan Karthikeyan, MD, DM, Department of Cardiology, All India Institute of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Ganesan Karthikeyan, Additional Professor of Cardiology, All India Institute of Medical Sciences, New Delhi
    ClinicalTrials.gov Identifier:
    NCT00232622
    Other Study ID Numbers:
    • A-29/3.3.2004
    First Posted:
    Oct 5, 2005
    Last Update Posted:
    Oct 24, 2013
    Last Verified:
    Oct 1, 2013
    Keywords provided by Dr Ganesan Karthikeyan, Additional Professor of Cardiology, All India Institute of Medical Sciences, New Delhi
    Prosthetic valve thrombosis
    Fibrinolysis
    Streptokinase
    Additional relevant MeSH terms:
    Thrombosis
    Streptokinase

    Study Results

    No Results Posted as of Oct 24, 2013