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

NCT00232622 | Completed Phase 3

• 1 other identifier: A-29/3.3.2004
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Prosthetic valve thrombosis; Fibrinolysis; Streptokinase

Outcome Measures

Primary Outcomes (1)

• The occurrence of a complete clinical response (complete hemodynamic response as assessed by echocardiography and fluoroscopy, without any major complication)

  In-hospital

Secondary Outcomes (1)

• Death, Major bleeding and minor bleeding

  In-hospital

Study Arms (2)

Standard infusion of streptokinase

ACTIVE COMPARATOR

Standard infusion of streptokinase

Drug: Streptokinase

Accelerated infusion of streptokinase

EXPERIMENTAL

Accelerated infusion of streptokinase

Drug: Streptokinase

Interventions

Streptokinase DRUG

Accelerated infusion of streptokinase

Also known as: Fibrinolytic therapy

Accelerated infusion of streptokinase

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• First episode of left sided prosthetic valve thrombosis

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Related Publications (3)

• Karthikeyan G, Math RS, Mathew N, Shankar B, Kalaivani M, Singh S, Bahl VK, Hirsh J, Eikelboom JW. Accelerated infusion of streptokinase for the treatment of left-sided prosthetic valve thrombosis: a randomized controlled trial. Circulation. 2009 Sep 22;120(12):1108-14. doi: 10.1161/CIRCULATIONAHA.109.876706. Epub 2009 Sep 8.

  PMID: 19738134 RESULT

• Karthikeyan G, Mathew N, Math RS, Devasenapathy N, Kothari SS, Bahl VK. Timing of adverse events during fibrinolytic therapy with streptokinase for left-sided prosthetic valve thrombosis. J Thromb Thrombolysis. 2011 Aug;32(2):146-9. doi: 10.1007/s11239-011-0579-4.

  PMID: 21416132 RESULT

• Barwad P, Raheja A, Venkat R, Kothari SS, Bahl V, Karthikeyan G. High prevalence of silent brain infarction in patients presenting with mechanical heart valve thrombosis. Am J Cardiovasc Drugs. 2012 Oct 1;12(5):345-8. doi: 10.1007/BF03261843.

  PMID: 22779430 DERIVED

MeSH Terms

Interventions

Streptokinase; Thrombolytic Therapy

Intervention Hierarchy (Ancestors)

Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Drug Therapy; Therapeutics

Study Officials

• Ganesan Karthikeyan, MD, DM

  Department of Cardiology, All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor of Cardiology

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 5, 2005
• Study Start: November 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: October 24, 2013

Record last verified: 2013-10