A Study Comparing a New Dosing Regimen of Clot-dissolving Drug for Mechanical Heart Valves Which Show Clots
NCT ID: NCT00232622
Last Updated: 2013-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2004-11-30
2007-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard infusion of streptokinase
Standard infusion of streptokinase
Streptokinase
Standard dose streptokinase
Accelerated infusion of streptokinase
Accelerated infusion of streptokinase
Streptokinase
Accelerated infusion of streptokinase
Interventions
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Streptokinase
Accelerated infusion of streptokinase
Streptokinase
Standard dose streptokinase
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Refusal to give informed consent
* Pregnant women
* age less than 12 years or more than 70 years
* previous treatment for prosthetic valve thrombosis
12 Years
70 Years
ALL
No
Sponsors
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All India Institute of Medical Sciences
OTHER
Responsible Party
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Dr Ganesan Karthikeyan
Additional Professor of Cardiology
Principal Investigators
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Ganesan Karthikeyan, MD, DM
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, All India Institute of Medical Sciences
Countries
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References
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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.
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: 10.1007/BF03261843.
Other Identifiers
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A-29/3.3.2004
Identifier Type: -
Identifier Source: org_study_id