Surgery Versus Fibrinolytic Therapy for Left-sided Prosthetic Heart Valve Thrombosis

NCT01641549 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: Version 1.01
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

Malfunction of mechanical heart valves due to clot formation is a potentially devastating complication. It often results in heart failure, death or stroke. This condition occurs frequently in patients with mechanical valves in developing countries because they are unable to monitor and adjust the dose of blood thinning medications. The best treatment modality for the treatment of patients with this condition is not known. There is no reliable data from clinical trials to guide treatment and there are no firm guidelines. Treatment with clot-busting drugs is most commonly used because these drugs (e.g., streptokinase) are readily available, cheap, and easy to use. However, this treatment is associated with high rates of treatment-related side-effects (death, life-threatening bleeding and stroke). Moreover, some recent studies suggest that clot-busting drugs may not be as efficacious in restoring valve function, as previously believed. Emergency surgery is less often used because it is more expensive and the required facilities and manpower are not available at all times at all places. But there is evidence to suggest that surgery results in better success rates with a lower risk of bleeding and stroke. Well-designed prospective randomised trials (the "gold-standard" for reliable evidence) comparing the efficacy, safety and cost-effectiveness of the two modalities, are needed to help doctors in developing countries make informed decisions when treating patients with clotted mechanical heart valves. The investigators propose to perform a randomised controlled trial comparing emergency surgery with treatment with clot-busting agents in patients with clotted mechanical valves. The study will be conducted over 4 years at a single, university hospital in a developing country. This study will determine how often patients who are treated with surgery will be discharged from hospital, with completely restored valve function, without having suffered a stroke or life-threatening bleeding, when compared to those who received clot-busting drugs. The investigators will also find out which of the treatments is safe and cost-effective.

Conditions

Left-sided Prosthetic Heart Valve Thrombosis

Keywords

Prosthetic valve thrombosis; Fibrinolytic therapy; Emergency surgery

Outcome Measures

Primary Outcomes (1)

• Complete clinical response

  The primary outcome is the occurrence of a complete clinical response, defined as discharge from hospital with completely restored valve function, in the absence of stroke, major bleeding or non-CNS systemic embolism.

  In-hospital, average of 10 days

Secondary Outcomes (2)

• Death, stroke, major bleeding, or non-CNS systemic embolism

  In-hospital, average of 10 days

• Death, recurrent PVT, stroke or non-CNS systemic embolism or persistent abnormal valve function

  1 year

Study Arms (2)

Emergency surgery

EXPERIMENTAL

Emergency surgery (valve replacement or thrombectomy)

Procedure: Emergency surgery

Fibrinolytic therapy

ACTIVE COMPARATOR

Streptokinase (SK) at a dose of 0.25MU over 30 minutes followed by a 0.1MU/ hour infusion, or other fibrinolytic agent

Drug: Fibrinolytic therapy

Interventions

Emergency surgery PROCEDURE

Emergency surgery (valve replacement or thrombectomy)

Also known as: Redo valve replacement

Emergency surgery

Fibrinolytic therapy DRUG

Streptokinase (SK) at a dose of 0.25MU over 30 minutes followed by a 0.1MU/ hour infusion, or other fibrinolytic agent at standard doses

Also known as: Thrombolytic therapy

Fibrinolytic therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients over 18 years of age with recent-onset (≤2 weeks), objectively diagnosed, symptomatic (NYHA class II-IV) left-sided prosthetic valve dysfunction

You may not qualify if:

• Absolute contraindications to FT (any history of intracranial hemorrhage, active bleeding from any site, ischemic stroke in the preceding 3 months, left atrial thrombus on TTE)
• Pregnant patients
• Asymptomatic patients (incidentally detected valve thrombosis)
• Inability to obtain (or refusal to provide) informed consent

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

Departments of cardiology and Cardiovascular Surgery, All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

MeSH Terms

Interventions

Thrombolytic Therapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Ganesan Karthikeyan, MD, DM, MSc

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ganesan Karthikeyan, MD, DM, MSc

CONTACT

+91-11-26594464; karthik2010@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor of Cardiology

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 17, 2012
• Study Start: April 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 10, 2017

Record last verified: 2017-03

Locations

IN (1)