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To Compare the Efficacy & Safety of Ultra-Slow (24 hr) Low Dose (25 mg) Infusion of Alteplase Over Slow (24hr) Infusion of Streptokinase in Mechanical Prosthetic Valve Thrombosis

NCT07360717 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-26

No results posted yet for this study

Summary

Annual incidence of PVT for mechanical valves is 0.3 - 1.3% patient-yrs. First postoperative year is marked by a 24% incidence of thrombosis. Stable incidence between the second to fourth years (\~ 15%), and a subsequent decrease afterward. Mortality rates of Re-do Surgery have been reported to be from 6% to 69% (average 12%) Thrombolytic therapy as a First-line strategy is being used with successful outcomes. To Study the Efficacy \& Safety of Low Dose (25 mg) Ultra-slow (24 hr) Infusion of Alteplase Without Bolus (max 72 hrs) over Slow (24hr) Infusion of 25 lac units Streptokinase (2.5 lac 1st hr → 1 lac /hr for 23 hrs) (max 48 hrs) in Mechanical PVT.

Objectives :

Primary :

To compare the success rate of USLD Alteplase thrombolysis over Streptokinase To compare the complication rates (minor + non-fatal major + fatal) in both the study groups

Secondary:

To study the clinical profile of patients presenting with Mechanical PVT. Single Centre Open Label Randomized Controlled Trial Sample Size : 100 (50 each) Follow up : Till Hospital Discharge Pt randomized as per Computer Generated Random Number Started on Inj Heparin Infusion till initiation of Thrombolysis. Repeat 2D Echo at 6 Hrs, 12 Hrs and 24 Hrs Interval \& as required. Repeat Fluoroscopy / TEE if Echocardiographic evidence of improvement in gradient or moving leaflets / at 24 hrs interval.

Extended Thrombolysis with STK (max 48 hrs) / Alteplase (Max 72 hrs) Restarting of Heparin Infusion In between time lags for next continuation of Thrombolysis / Surgery/ attaining Therapeutic INR Post-thrombolysis Follow up till Discharge for Outcome

Conditions

  • Thrombolysed

Interventions

DRUG

Alteplase

Low Dose (25 mg) Ultra-slow (24 hr) Infusion of Alteplase Without Bolus (max 72 hrs)

DRUG

streptokinase

Slow (24hr) Infusion of 25 lac units Streptokinase (2.5 lac 1st hr → 1 lac /hr for 23 hrs) (max 48 hrs)

Sponsors & Collaborators

  • U. N. Mehta Institute of Cardiology and Research Center

    lead OTHER

Principal Investigators

  • Sibasis Sahoo, DM · U. N. Mehta Institute of Cardiology and Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • India

Study Locations

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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 NCT07360717 on ClinicalTrials.gov