NCT01451320

Brief Summary

Despite high mortality and morbidity, the best treatment strategies for prosthetic valve thrombosis (PVT) have been controversial. In this study the investigators wanted to identify the most effective and safe regimen among different thrombolytic strategies.Transesophageal echocardiography (TEE) guided thrombolytic treatment was administered to 182 consecutive patients with PVT in 220 different episodes (156 women, mean age 43.2±13.06 years) between 1993 and 2009. These regimens included rapid streptokinase (Group I, 16 episodes), slow streptokinase (Group II, 41 episodes), high dose (100 mg) tissue plasminogen activator (t-PA) (Group III, 12 episodes), half-dose (50 mg) slow infusion (6-hours) of t-PA without bolus (Group IV, 27 episodes), and low dose (25 mg) and slow infusion (6-hours) of t-PA without bolus (Group V, 124 episodes). The study endpoints were thrombolytic success and in-hospital mortality and non-fatal complication rates.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 1993

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1993

Completed
16.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 13, 2011

Completed
Last Updated

October 13, 2011

Status Verified

October 1, 2011

Enrollment Period

16.9 years

First QC Date

September 29, 2011

Last Update Submit

October 11, 2011

Conditions

Prosthetic Valve Thrombosis

Keywords

Prosthetic valvethrombosisTROIAtPATEE

Outcome Measures

Primary Outcomes (3)

  • Thrombolytic success

    In the absence of fatal or nonfatal major complications; * Obstructive thrombus: 1. Doppler documentation of the resolution of increased gradient and decreased valve area. 2. Clinical improvement in symptoms. 3. Reduction by ≥75% in major diameter or area of the thrombus. Complete success was defined when all 3 criteria were met and partial success was defined as less than 3. * Nonobstrucive thrombus: 1. Complete success: ≥75% reduction in thrombus area. 2. Partial success: 50%-75% reduction in thrombus area.

    24 hours

  • Non-fatal complication rates

    * Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion. * Nonfatal minor complication: Bleeding without need for transfusion, TIA.

    participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  • In-hospital mortality

    All cause in-hospital mortality.

    participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Study Arms (5)

rapid streptokinase

ACTIVE COMPARATOR

3-hour infusion of 1.5 million units of streptokinase (16 patients, 16 episodes), repeat once 24 hours later if needed (maximum total dose 3 million units).

Drug: Streptokinase

high dose tpa

ACTIVE COMPARATOR

5-hour infusion of 90 mg t-PA(Tissue plasminogen activator) after 10 mg bolus (10 patients, 12 episodes), repeat once 24 hours later if needed (maximum total dose 200 mg)

Drug: Tissue plasminogen activator

slow streptokinase

ACTIVE COMPARATOR

24-hour infusion of 1.5 million units of streptokinase (41 patients, 41 episodes), repeat once 24 hours later if needed (maximum total dose 3 million units).

Drug: Streptokinase

half-dose slow infusion tpa

ACTIVE COMPARATOR

6-hour infusion of 50 mg t-PA (Tissue plasminogen activator) without bolus (27 patients, 27 episodes), repeat once 24 hours later up to 3 times if needed (maximum total dose 150 mg).

Drug: Tissue Plasminogen Activator

low dose slow infusion tpa

ACTIVE COMPARATOR

6-hour infusion of 25 mg t-PA(Tissue plasminogen activator) without bolus (108 patients, 124 episodes), repeat once 24 hours later up to 6 times if needed (maximum total dose 150 mg).

Drug: Tissue Plasminogen Activator

Interventions

StreptokinaseDRUG

3-hour infusion of 1.5 million units of streptokinase (16 patients, 16 episodes), repeat once 24 hours later if needed (maximum total dose 3 million units)

Also known as: Streptase
rapid streptokinase
Tissue Plasminogen ActivatorDRUG

5-hour infusion of 90 mg t-PA (Tissue plasminogen activator) after 10 mg bolus (10 patients, 12 episodes), repeat once 24 hours later if needed (maximum total dose 200 mg)

Also known as: ACTILYSE
high dose tpa

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with prosthetic valve thrombosis

You may not qualify if:

  • Large left atrial thrombus
  • Recent (\<3 weeks) ischemic stroke
  • Hemorrhagic stroke
  • Early (\<4 days) postoperative period
  • Traumatic accident \<4 weeks
  • Bleeding diathesis †
  • İntracranial mass
  • Active internal bleed
  • Aortic dissection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kosuyolu Kartal Heart Training and Research Hospital

Istanbul, 34844, Turkey (Türkiye)

Location

Related Publications (2)

  • Ozkan M, Kaymaz C, Kirma C, Sonmez K, Ozdemir N, Balkanay M, Yakut C, Deligonul U. Intravenous thrombolytic treatment of mechanical prosthetic valve thrombosis: a study using serial transesophageal echocardiography. J Am Coll Cardiol. 2000 Jun;35(7):1881-9. doi: 10.1016/s0735-1097(00)00654-9.

    PMID: 10841239BACKGROUND

  • Ozkan M, Gunduz S, Biteker M, Astarcioglu MA, Cevik C, Kaynak E, Yildiz M, Oguz E, Aykan AC, Erturk E, Karavelioglu Y, Gokdeniz T, Kaya H, Gursoy OM, Cakal B, Karakoyun S, Duran N, Ozdemir N. Comparison of different TEE-guided thrombolytic regimens for prosthetic valve thrombosis: the TROIA trial. JACC Cardiovasc Imaging. 2013 Feb;6(2):206-16. doi: 10.1016/j.jcmg.2012.10.016.

    PMID: 23489534DERIVED

MeSH Terms

Conditions

Thrombosis

Interventions

StreptokinaseTissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerine EndopeptidasesSerine ProteasesBiological Factors

Study Officials

  • Mehmet Ozkan, Assoc.Prof.

    Kosuyolu Kartal Heart Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD., FESC., Assoc. Prof,. Head of Cardiology

Study Record Dates

First Submitted

September 29, 2011

First Posted

October 13, 2011

Study Start

January 1, 1993

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 13, 2011

Record last verified: 2011-10

Locations

TU(1)