A Study Comparing a New Dosing Regimen of Clot-dissolving Drug for Mechanical Heart Valves Which Show Clots (RAFT-PVT)
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ClinicalTrials.gov Identifier: NCT00232622 |
Recruitment Status
:
Completed
First Posted
: October 5, 2005
Last Update Posted
: October 24, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prosthetic Valve Thrombosis | Drug: Streptokinase | Phase 3 |
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 (Clinical Trial) |
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 : | November 2004 |
Actual Primary Completion Date : | March 2007 |
Actual Study Completion Date : | March 2007 |

Arm | Intervention/treatment |
---|---|
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
|
- The occurrence of a complete clinical response (complete hemodynamic response as assessed by echocardiography and fluoroscopy, without any major complication) [ Time Frame: In-hospital ]
- Death, Major bleeding and minor bleeding [ Time Frame: In-hospital ]

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Ages Eligible for Study: | 12 Years to 70 Years (Child, Adult, Senior) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232622
Principal Investigator: | Ganesan Karthikeyan, MD, DM | Department of Cardiology, All India Institute of Medical Sciences |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
First Posted: | October 5, 2005 Key Record Dates |
Last Update Posted: | October 24, 2013 |
Last Verified: | October 2013 |
Keywords provided by Dr Ganesan Karthikeyan, All India Institute of Medical Sciences, New Delhi:
Prosthetic valve thrombosis Fibrinolysis Streptokinase |
Additional relevant MeSH terms:
Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Streptokinase Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |