Prosthetic Valve ThrombosisTROIANCT01451320
Comparison of Different TRansesophageal Echocardiography Guided thrOmbolytic Regimens for prosthetIc vAlve Thrombosis
A study testing Streptokinase and Tissue plasminogen activator in people with Prosthetic Valve Thrombosis, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prosthetic Valve Thrombosis
- What is being tested?
- Streptokinase and Tissue plasminogen activator
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 1993to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with prosthetic valve thrombosis
Who cannot join
- Large left atrial thrombus
- Recent (<3 weeks) ischemic stroke
- Hemorrhagic stroke
- Early (<4 days) postoperative period
- Traumatic accident <4 weeks
- Bleeding diathesis †
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- İntracranial mass
- Active internal bleed
- Aortic dissection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kosuyolu Kartal Heart Training and Research Hospital
Istanbul, 34844
About this study
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.
Read the detailed description
One hundred and eighty two consecutive in-hospital patients with 220 episodes of PVT between 1993 and 2009 were included in the study. The patients were enrolled after informed consent if there was no contraindication, to thrombolysis. The study was approved by the local Ethics Board. The patient demographics, past medical history, date of the operation, type and make of the prosthetic valve, rhythm disorders, aspirin use, NYHA functional capacity, leading symptoms and international normalization ratio (INR) values at the time of admission were prospectively entered into a database.The diagnosis of PVT was verified each time by transesophageal echocardiography (TEE) when a patient was admitted with thromboembolism or persistently low INR for the preceding consecutive 3 months and when a transthoracic echocardiography (TTE) documented prosthetic valve dysfunction or thrombus. All patients underwent TTE and TEE examination before and after the thrombolysis sessions. The cross sectional area and the longest diameter of the thrombus were measured on TEE recordings
- Conditions
- Prosthetic Valve Thrombosis
- Being tested
- Streptokinase, Tissue plasminogen activator
- Keywords
- Prosthetic valve, thrombosis, TROIA, tPA, TEE
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StreptokinaseDrug
Also called Streptase
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)
StreptokinaseDrug
Also called Streptase
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).
Tissue plasminogen activatorDrug
Also called ACTILYSE
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)
Tissue Plasminogen ActivatorDrug
Also called ACTILYSE
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).
Tissue Plasminogen ActivatorDrug
Also called ACTILYSE
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: 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). Receives: 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). Receives: 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). Receives: Drug: Tissue Plasminogen Activator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombolytic success
In the absence of fatal or nonfatal major complications;
- Obstructive thrombus:
- Doppler documentation of the resolution of increased gradient and decreased valve area.
- Clinical improvement in symptoms.
- 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:
- Complete success: ≥75% reduction in thrombus area.
- Partial success: 50%-75% reduction in thrombus area.
Measured: 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.
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
In-hospital mortality
All cause in-hospital mortality.
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startJan 1993
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prosthetic Valve ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, MEHMET OZKAN, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Investigators
- Mehmet Ozkan, Assoc.Prof., Principal investigator, Kosuyolu Kartal Heart Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451320
- Sponsor's protocol ID
- 11
- Acronym
- TROIA
- Status last verified
- Oct 2011
- First submitted
- 29 Sep 2011
- Last updated
- 13 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10841239Ozkan 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.
PubMed 23489534
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different TRansesophageal Echocardiography Guided thrOmbolytic Regimens for prosthetIc vAlve Thrombosis
- ClinicalTrials.gov ID
- NCT01451320
- Acronym / sponsor ID
- TROIA / 11
- Conditions
- Prosthetic Valve Thrombosis
- Keywords
- Prosthetic valve, thrombosis, TROIA, tPA, TEE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitalOther government
- Study start
- Jan 1993
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
One hundred and eighty two consecutive in-hospital patients with 220 episodes of PVT between 1993 and 2009 were included in the study. The patients were enrolled after informed consent if there was no contraindication, to thrombolysis. The study was approved by the local Ethics Board. The patient demographics, past medical history, date of the operation, type and make of the prosthetic valve, rhythm disorders, aspirin use, NYHA functional capacity, leading symptoms and international normalization ratio (INR) values at the time of admission were prospectively entered into a database.The diagnosis of PVT was verified each time by transesophageal echocardiography (TEE) when a patient was admitted with thromboembolism or persistently low INR for the preceding consecutive 3 months and when a transthoracic echocardiography (TTE) documented prosthetic valve dysfunction or thrombus. All patients underwent TTE and TEE examination before and after the thrombolysis sessions. The cross sectional area and the longest diameter of the thrombus were measured on TEE recordings
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| rapid streptokinase | Active comparator | Drug: Streptokinase3-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). |
| high dose tpa | Active comparator | Drug: Tissue plasminogen activator5-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) |
| slow streptokinase | Active comparator | Drug: Streptokinase24-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). |
| half-dose slow infusion tpa | Active comparator | Drug: Tissue Plasminogen Activator6-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). |
| low dose slow infusion tpa | Active comparator | Drug: Tissue Plasminogen Activator6-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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with prosthetic valve thrombosis
Key exclusion criteria (9 listed)
- Large left atrial thrombus
- Recent (<3 weeks) ischemic stroke
- Hemorrhagic stroke
- Early (<4 days) postoperative period
- Traumatic accident <4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StreptokinaseAlso: Streptase3-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 | rapid streptokinase |
| StreptokinaseAlso: Streptase24-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 | slow streptokinase |
| Tissue plasminogen activatorAlso: ACTILYSE5-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 | high dose tpa |
| Tissue Plasminogen ActivatorAlso: ACTILYSE6-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 | half-dose slow infusion tpa |
| Tissue Plasminogen ActivatorAlso: ACTILYSE6-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 | low dose slow infusion tpa |
Primary outcome
Thrombolytic success
Time frame: 24 hours
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.
Non-fatal complication rates
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
* Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion. * Nonfatal minor complication: Bleeding without need for transfusion, TIA.
In-hospital mortality
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
All cause in-hospital mortality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2011.
- Background: PubMed 10841239Ozkan 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.
- Derived from this study: PubMed 23489534Ozkan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Ozkan, Assoc.Prof. principal investigator
Kosuyolu Kartal Heart Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Streptokinase and Tissue plasminogen activator in people with Prosthetic Valve Thrombosis, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombolytic success (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01451320, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2011.