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Completed

NCT Number: NCT00232622

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

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.

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Key information

Conditions

Prosthetic Valve Thrombosis

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Streptokinase

Drug

Accelerated infusion of streptokinase

Other names: Fibrinolytic therapy

Primary outcomes

  1. The occurrence of a complete clinical response (complete hemodynamic response as assessed by echocardiography and fluoroscopy, without any major complication)

    Time frame: In-hospital

Secondary outcomes

  1. Death, Major bleeding and minor bleeding

    Time frame: In-hospital

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

A Prospective Randomized Trial of a Rapid Fibrinolytic Protocol for Left-sided Prosthetic Valve Thrombosis

Acronym: RAFT-PVT

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Oct 5, 2005
Registry last updated
Oct 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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