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

All India Institute Of Medical Science (AIIMS)

Status and phase: Completed; Phase 3

Conditions: Prosthetic Valve Thrombosis

Treatments: Drug: Streptokinase

Study type: Interventional

Funder types: Other

Identifiers

NCT00232622

A-29/3.3.2004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Standard infusion of streptokinase

Active Comparator group

Description:

Standard infusion of streptokinase

Treatment:

Drug: Streptokinase

Drug: Streptokinase

Accelerated infusion of streptokinase

Experimental group

Description:

Accelerated infusion of streptokinase

Treatment:

Drug: Streptokinase

Drug: Streptokinase