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

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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) [ Time Frame: In-hospital ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Death, Major bleeding and minor bleeding [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]


Enrollment:	120
Study Start Date:	November 2004
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Standard infusion of streptokinase Standard infusion of streptokinase	Drug: Streptokinase Standard dose streptokinase Other Name: Fibrinolytic therapy
Experimental: Accelerated infusion of streptokinase Accelerated infusion of streptokinase	Drug: Streptokinase Accelerated infusion of streptokinase Other Name: Fibrinolytic therapy

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

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

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

Publications:

Karthikeyan G, Math RS, Mathew N, Shankar B, Kalaivani M, Singh S, Bahl VK, Hirsh J, Eikelboom JW. Accelerated infusion of streptokinase for the treatment of left-sided prosthetic valve thrombosis: a randomized controlled trial. Circulation. 2009 Sep 22;120(12):1108-14. doi: 10.1161/CIRCULATIONAHA.109.876706. Epub 2009 Sep 8.

Karthikeyan G, Mathew N, Math RS, Devasenapathy N, Kothari SS, Bahl VK. Timing of adverse events during fibrinolytic therapy with streptokinase for left-sided prosthetic valve thrombosis. J Thromb Thrombolysis. 2011 Aug;32(2):146-9. doi: 10.1007/s11239-011-0579-4.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Barwad P, Raheja A, Venkat R, Kothari SS, Bahl V, Karthikeyan G. High prevalence of silent brain infarction in patients presenting with mechanical heart valve thrombosis. Am J Cardiovasc Drugs. 2012 Oct 1;12(5):345-8. doi: 10.2165/11632560-000000000-00000.


Responsible Party:	Dr Ganesan Karthikeyan, Additional Professor of Cardiology, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:	NCT00232622 History of Changes
Other Study ID Numbers:	A-29/3.3.2004
Study First Received:	October 3, 2005
Last Updated:	October 23, 2013
Health Authority:	India: Ministry of Health

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


Prosthetic valve thrombosis Fibrinolysis Streptokinase

Additional relevant MeSH terms:


Thrombosis Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases Streptokinase Cardiovascular Agents	Fibrin Modulating Agents Fibrinolytic Agents Hematologic Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015

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