A Study Comparing a New Dosing Regimen of Clot-Dissolving Drug for Mechanical Heart Valves Which Show Clots - Full Text View

Sponsored by:	All India Institute of Medical Sciences, New Delhi
Information provided by:	All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:	NCT00232622

Purpose

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	Intervention	Phase
Prosthetic Valve Thrombosis	Drug: Streptokinase	Phase III

Drug Information available for: Streptokinase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective Randomized Trial of a Rapid Fibrinolytic Protocol for Left-Sided Prosthetic Valve Thrombosis

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Death, Major bleeding and minor bleeding

Estimated Enrollment:	116
Study Start Date:	November 2004
Study Completion Date:	March 2007

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.

Eligibility

Ages Eligible for Study:	12 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232622

Locations

India, Delhi
Department of cardiology, All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029

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

More Information

Study ID Numbers:	A-29/3.3.2004
Study First Received:	October 3, 2005
Last Updated:	April 3, 2007
ClinicalTrials.gov Identifier:	NCT00232622
Health Authority:	India: Ministry of Health

Keywords provided by All India Institute of Medical Sciences, New Delhi:

Prosthetic valve thrombosis
Fibrinolysis
Streptokinase

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases
Streptokinase
Thrombosis

Additional relevant MeSH terms:

Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009