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

NCT00232622 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-10-24

No results posted yet for this study

Summary

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.

Conditions

  • Prosthetic Valve Thrombosis

Interventions

DRUG

Streptokinase

Accelerated infusion of streptokinase

DRUG

Streptokinase

Standard dose streptokinase

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Ganesan Karthikeyan, MD, DM · Department of Cardiology, All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2007-03-31
Completion
2007-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00232622 on ClinicalTrials.gov