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
  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:
Additional 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
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 October 22, 2014