Pulmonary EmbolismPhase 4NCT02029456
Low Dose Prolonged Infusion of Tissue Type Plasminogen Activator Therapy in Massive Pulmonary Embolism
A Phase 4 study testing 25 mg Actilyse ( Boehringer Ingelheim, Germany) infusion in 6 hours in people with Pulmonary Embolism, run by Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study was to assess the effects of low-dose (25mg) prolonged administration (in 6 hours) of tissue type plasminogen activator (tPA) on in-hospital mortality and outcomes in patients with massive PE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- 25 mg Actilyse ( Boehringer Ingelheim, Germany) infusion in 6 hours
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2011to Aug 2014
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with massive PE aged 18 years or older with confirmed PE and able to give informed consent will be included in the study. PE is defined according to current guidelines as adult patients presenting with signs and symptoms suggestive of PE plus imaging documentation on computed tomography angiography. Massive PE was defined as acute PE with sustained hypotension (systolic blood pressure<90 mm Hg for at least 15 minutes or requiring inotropic support, not due to a cause other than PE, such as arrhythmia, hypovolemia, sepsis, or left ventricular [LV] dysfunction), pulselessness, or persistent profound bradycardia (heart rate<40 bpm with signs or symptoms of shock).
Who cannot join
- Patients with prior intracranial hemorrhage, known structural intracranial cerebrovascular disease (eg, arteriovenous malformation), known malignant intracranial neoplasm, ischemic stroke within 3 months, suspected aortic dissection, active bleeding or bleeding diathesis, recent surgery encroaching on the spinal canal or brain, and recent significant closed-head or facial trauma with radiographic evidence of bony fracture or brain injury were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Department of Cardiology, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Trabzon, 61040
AHMET Ç AYKAN, MD
About this study
Official title: Low Dose Prolonged Infusion of Tissue Type Plasminogen Activator Therapy in Massive Pulmonary Embolism: AYKAN Trial
The aim of the present study was to assess the effects of low-dose (25mg) prolonged administration (in 6 hours) of tissue type plasminogen activator (tPA) on in-hospital mortality and outcomes in patients with massive PE.
Read the detailed description
Pulmonary embolism (PE) is life threatening disease requiring early diagnosis and treatment. Thrombolytic therapy (TT) is required in patients with massive PE. PE has a high mortality but the in-hospital all-cause case mortality rates were lower in unstable patients who received TT than those who did not. However, it was reported that minority (nearly 30%) of unstable patients received thrombolytic therapy. The reason that majority of unstable patients failed to receive thrombolytic therapy is unclear. The higher rates of complications including the life threatening bleeding may be a reason of reluctance in the use of TT.
The lungs are the only organ receiving the entire cardiac output. Therefore, they are the point of convergence for the entire molecules of the thrombolytic agent, independent from the route of administration. So that lower doses of the TT might be effective in PE, with the additional benefits of enhancing its safety profile. The percutaneous endovenous intervention for deep venous thrombosis has suggested an exquisitely favorable pulmonary response to low-dose thrombolysis. The aim of the present study was to assess the effects of low-dose (25mg) prolonged administration (in 6 hours) of tissue type plasminogen activator (tPA) on in-hospital mortality and outcomes in patients with massive PE.
The primary end points consisted of in hospital all cause mortality, major complications, pulmonary hypertension and right ventricular dysfunction. Secondary points are all cause mortality, pulmonary hypertension and right ventricular dysfunction at 6 month.
- Conditions
- Pulmonary Embolism
- Being tested
- 25 mg Actilyse ( Boehringer Ingelheim, Germany) infusion in 6 hours
- Keywords
- Massive Pulmonary embolism, thrombolytic therapy, high risk, elderly
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25 mg Actilyse ( Boehringer Ingelheim, Germany) infusion in 6 hoursDrug
| Study group | Role | What they receive |
|---|---|---|
| Low dose prolonged infusion arm | Experimental | Low dose prolonged infusion of tPA arm (25mg Actilyse in 6 hours) Receives: Drug: 25 mg Actilyse ( Boehringer Ingelheim, Germany) infusion in 6 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause in hospital mortality
Death occured during hospitalization period.
Measured: participants will be followed for the duration of hospital stay, an expected average of 7 days
Major complications
Major bleeding, intracranial bleeding, resuscitated cardiac arrest, thromboembolism and stroke are described as major complications.
Measured: participants will be followed for the duration of hospital stay, an expected average of 7 days.
Development of pulmonary hypertension
Pulmonary artery systolic pressure >40mmHg measured by transthoracic echocardiography prior to discharge was described as pulmonary hypertension.
Measured: participants will be followed for the duration of hospital stay, an expected average of 7 days
Right Ventricular dysfunction
Right ventricular dysfunction detected by transthoracic echocardiography:
- Decreased right ventricular diameter (at least 25% decrease of Right ventricle/Left ventricle diameter)
- Tricuspid annular plane systolic excursion>16mm)
- s'> 10.0 cm/s
- Tissue Doppler derived right ventricle myocardial performance index>0.55
Measured: participants will be followed for the duration of hospital stay, an expected average of 7 days
Restoration of hemodynamic status
Systolic blood pressure >100mmHG
Measured: 6 hours after the beginning of thrombolytic therapy
Secondary outcomes (2)
Pulmonary hypertension
Pulmonary artery systolic pressure >40mmHg
Measured: 6 month
Right ventricular dysfunction
- Tricuspid annular plane systolic excursion >16mm
- s'> 10.0 cm/s
- Tissue Doppler derived right ventricle myocardial performance index>0.55
- Right ventricle/Left ventricle diameter <1
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startJun 2011
- Primary completionMar 2014 (estimated)
- Study completionAug 2014 (estimated)
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 Pulmonary EmbolismStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMET CAGRI AYKAN, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
- Investigators
- Ahmet Ç AYKAN, MD, Study chair, Department of Cardiology, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029456
- Sponsor's protocol ID
- 538.38792-903/6190
- Status last verified
- Jan 2014
- First submitted
- 17 Nov 2013
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ozkan M, Cakal B, Karakoyun S, Gursoy OM, Cevik C, Kalcik M, Oguz AE, Gunduz S, Astarcioglu MA, Aykan AC, Bayram Z, Biteker M, Kaynak E, Kahveci G, Duran NE, Yildiz M. Thrombolytic therapy for the treatment of prosthetic heart valve thrombosis in pregnancy with low-dose, slow infusion of tissue-type plasminogen activator. Circulation. 2013 Jul 30;128(5):532-40. doi: 10.1161/CIRCULATIONAHA.113.001145. Epub 2013 Jun 28.
PubMed 23812180Ozkan 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 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Prolonged Infusion of Tissue Type Plasminogen Activator Therapy in Massive Pulmonary Embolism: AYKAN Trial
- ClinicalTrials.gov ID
- NCT02029456
- Acronym / sponsor ID
- 538.38792-903/6190
- Conditions
- Pulmonary Embolism
- Keywords
- Massive Pulmonary embolism, thrombolytic therapy, high risk, elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ahi Evren Chest and Cardiovascular Surgery Education and Research HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 8 Jan 2014 (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.
The aim of the present study was to assess the effects of low-dose (25mg) prolonged administration (in 6 hours) of tissue type plasminogen activator (tPA) on in-hospital mortality and outcomes in patients with massive PE.
Detailed description
Pulmonary embolism (PE) is life threatening disease requiring early diagnosis and treatment. Thrombolytic therapy (TT) is required in patients with massive PE. PE has a high mortality but the in-hospital all-cause case mortality rates were lower in unstable patients who received TT than those who did not. However, it was reported that minority (nearly 30%) of unstable patients received thrombolytic therapy. The reason that majority of unstable patients failed to receive thrombolytic therapy is unclear. The higher rates of complications including the life threatening bleeding may be a reason of reluctance in the use of TT.
The lungs are the only organ receiving the entire cardiac output. Therefore, they are the point of convergence for the entire molecules of the thrombolytic agent, independent from the route of administration. So that lower doses of the TT might be effective in PE, with the additional benefits of enhancing its safety profile. The percutaneous endovenous intervention for deep venous thrombosis has suggested an exquisitely favorable pulmonary response to low-dose thrombolysis. The aim of the present study was to assess the effects of low-dose (25mg) prolonged administration (in 6 hours) of tissue type plasminogen activator (tPA) on in-hospital mortality and outcomes in patients with massive PE.
The primary end points consisted of in hospital all cause mortality, major complications, pulmonary hypertension and right ventricular dysfunction. Secondary points are all cause mortality, pulmonary hypertension and right ventricular dysfunction at 6 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low dose prolonged infusion arm | Experimental | Drug: 25 mg Actilyse ( Boehringer Ingelheim, Germany) infusion in 6 hoursLow dose prolonged infusion of tPA arm (25mg Actilyse in 6 hours) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with massive PE aged 18 years or older with confirmed PE and able to give informed consent will be included in the study. PE is defined according to current guidelines as adult patients presenting with signs and symptoms suggestive of PE plus imaging documentation on computed tomography angiography. Massive PE was defined as acute PE with sustained hypotension (systolic blood pressure<90 mm Hg for at least 15 minutes or requiring inotropic support, not due to a cause other than PE, such as arrhythmia, hypovolemia, sepsis, or left ventricular [LV] dysfunction), pulselessness, or persistent profound bradycardia (heart rate<40 bpm with signs or symptoms of shock).
Key exclusion criteria (1 listed)
- Patients with prior intracranial hemorrhage, known structural intracranial cerebrovascular disease (eg, arteriovenous malformation), known malignant intracranial neoplasm, ischemic stroke within 3 months, suspected aortic dissection, active bleeding or bleeding diathesis, recent surgery encroaching on the spinal canal or brain, and recent significant closed-head or facial trauma with radiographic evidence of bony fracture or brain injury were excluded from the study.
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 |
|---|---|---|
| 25 mg Actilyse ( Boehringer Ingelheim, Germany) infusion in 6 hours | Drug | Low dose prolonged infusion arm |
Primary outcome
All cause in hospital mortality
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
Death occured during hospitalization period.
Major complications
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days.
Major bleeding, intracranial bleeding, resuscitated cardiac arrest, thromboembolism and stroke are described as major complications.
Development of pulmonary hypertension
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
Pulmonary artery systolic pressure >40mmHg measured by transthoracic echocardiography prior to discharge was described as pulmonary hypertension.
Right Ventricular dysfunction
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
Right ventricular dysfunction detected by transthoracic echocardiography: 1. Decreased right ventricular diameter (at least 25% decrease of Right ventricle/Left ventricle diameter) 2. Tricuspid annular plane systolic excursion>16mm) 3. s'> 10.0 cm/s 4. Tissue Doppler derived right ventricle myocardial performance index>0.55
Restoration of hemodynamic status
Time frame: 6 hours after the beginning of thrombolytic therapy
Systolic blood pressure >100mmHG
2 secondary outcomes
Pulmonary hypertension
Time frame: 6 month
Right ventricular dysfunction
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
- Results publication: PubMed 23812180Ozkan M, Cakal B, Karakoyun S, Gursoy OM, Cevik C, Kalcik M, Oguz AE, Gunduz S, Astarcioglu MA, Aykan AC, Bayram Z, Biteker M, Kaynak E, Kahveci G, Duran NE, Yildiz M. Thrombolytic therapy for the treatment of prosthetic heart valve thrombosis in pregnancy with low-dose, slow infusion of tissue-type plasminogen activator. Circulation. 2013 Jul 30;128(5):532-40. doi: 10.1161/CIRCULATIONAHA.113.001145. Epub 2013 Jun 28.
- Results publication: 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.
Ahmet Ç AYKAN, MD study chair
Department of Cardiology, Ahi Evren Chest and Cardiovascular Surgery Education 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 Phase 4 study testing 25 mg Actilyse ( Boehringer Ingelheim, Germany) infusion in 6 hours in people with Pulmonary Embolism, run by Ahi Evren Chest and Cardiovascular Surgery 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 1 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: status not confirmed, as of the sponsor's last update on 8 Jan 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmet Ç Aykan, MD (905058689461, ahmetaykan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause in hospital mortality (time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days). The study lists 5 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 NCT02029456, 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 8 Jan 2014.