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

October 23, 2013 updated by: Dr Ganesan Karthikeyan, All India Institute of Medical Sciences, New Delhi

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.

Study Overview

Status

Completed

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard infusion of streptokinase
Accelerated infusion of streptokinase
Other Names:
  • Fibrinolytic therapy
Standard dose streptokinase
Other Names:
  • Fibrinolytic therapy
Experimental: Accelerated infusion of streptokinase
Accelerated infusion of streptokinase
Other Names:
  • Fibrinolytic therapy
Standard dose streptokinase
Other Names:
  • Fibrinolytic therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

October 3, 2005

First Submitted That Met QC Criteria

October 3, 2005

First Posted (Estimate)

October 5, 2005

Study Record Updates

Last Update Posted (Estimate)

October 24, 2013

Last Update Submitted That Met QC Criteria

October 23, 2013

Last Verified

October 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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