Acute Myocardial InfarctionPhase 4NCT00302419
Effect of Complementary Intracoronary Streptokinase Administration Immediately After Primary Percutaneous Coronary Intervention on Microvascular Perfusion and Late Term Infarct Size in Patients With Acute Myocardial Infarction
A Phase 4 study testing intracoronary infusion, and primary percutaneous coronary angioplasty in people with Acute Myocardial Infarction, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The investigators hypothesized that complementary intracoronary streptokinase administration to primary percutaneous intervention in patients with acute myocardial infarction may provide further improvement in myocardial perfusion by dissolving microvascular thrombus [in situ formed or embolized from proximal site… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- intracoronary infusion, and primary percutaneous coronary angioplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2004to Feb 2008
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Continuous chest pain that lasted > 30 minutes within the preceding 12 hours
- ST-segment elevation of at least 1 mm in 2 contiguous leads on the 12 leads ECG
- Infarct related artery (IRA) occlusion (TIMI grade 0) at the angiography
- Angiographically detected culprit coronary artery lesion deemed suitable for PCI
Who cannot join
- Contraindications to streptokinase, tirofiban, aspirin, clopidogrel, or heparin
- Culprit lesion in saphenous vein graft
- TIMI grade II-III flow in IRA
- Additional epicardial stenosis in the IRA distal to stented segment (significant or insignificant)
- Presence of left bundle branch block
- History of prior MI
- Mechanical ventilation or inotropic support
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul School of Medicine, Department of Cardiology
Istanbul, 34290
About this study
The investigators hypothesized that complementary intracoronary streptokinase administration to primary percutaneous intervention in patients with acute myocardial infarction may provide further improvement in myocardial perfusion by dissolving microvascular thrombus [in situ formed or embolized from proximal site (spontaneous or following PCI)] and fibrin.
Read the detailed description
Mechanical reperfusion for acute myocardial infarction (AMI) targets optimal revascularization of the epicardial artery but also aims at improved myocardial salvage. The goal of reperfusion therapies has shifted to include reperfusion downstream at the level of capillary bed, and it might be more appropriate that the hypothesis now be termed "the time dependent open artery and open microvascular hypothesis." Failure to achieve myocardial reperfusion despite the presence of a patent coronary artery has been termed the "no-reflow" phenomenon and attributed to microvascular dysfunction. It has become apparent that clinical outcomes are not only associated with patency of the epicardial artery, but also with patency of the microcirculation. Persistent impairment of microcirculation is associated with poor clinical outcome. Complete reperfusion in AMI settings necessitates reopening of the all consecutive vascular compartments all the way through the coronary circulation. But, embolization following percutaneous coronary intervention (PCI) and in situ microthrombi generation at the microvascular level makes this goal difficult to achieve. For this reason, mechanical intervention to the epicardial coronary artery with or without using distal protection wouldn't be enough to achieve ideal reperfusion at the ultimate (microvascular) level. At this point, it has become more evident that we need to develop more competent and feasible reperfusion strategies which can help us to achieve reperfusion as complete as possible at all levels.
Hypothesis:
Complementary intracoronary streptokinase administration to primary PCI may provide further improvement in myocardial perfusion by dissolving microvascular thrombus [in situ formed or embolized from proximal site (spontaneous or following PCI)] and fibrin. Improvement in microvascular perfusion may translate into reduction in infarct size and improvement in left ventricular function at long term.
- Conditions
- Acute Myocardial Infarction
- Being tested
- intracoronary infusion,, primary percutaneous coronary angioplasty
- Keywords
- Acute myocardial infarction, primary angioplasty, streptokinase, microvasculature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracoronary infusion,Drug
Also called Streptase
streptokinase, 250,000 units
primary percutaneous coronary angioplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Following standard primary percutaneous coronary intervention for ST elevation acute myocardial infarction 250.000 U intracoronary Streptokinase will be given Receives: Drug: intracoronary infusion,; Procedure: primary percutaneous coronary angioplasty |
| 2 | Active comparator | Standard percutaneous coronary intervention for ST elevation myocardial infarction will be performed Receives: Procedure: primary percutaneous coronary angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary end points defined as the indices of the microvascular perfusion which is going to be assessed on day 2 (48 hours after the primary PCI)and infarct size at 6 months.
Measured: 6 months
Index of microvascular resistance,
Measured: 48 hours
Coronary flow reserve
Measured: 48 hours
Left ventricular infarct size by SPECT at six months.
Measured: 6 months
Secondary outcomes (3)
Death
Measured: 1 year
Reinfarction
Measured: 1 month
Major bleeding
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startOct 2004
- Primary completionFeb 2006
- Study completionFeb 2008
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 Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Investigators
- Murat Sezer, M.D., Study director, Istanbul University, Istanbul School of MedicineSabahattin Umman, Prof., Principal investigator, Istanbul University, Istanbul School of MedicineTaner Goren, Prof., Study chair, Istanbul University, Istanbul School of MedicineHuseyin Oflaz, Assoc.Prof., Study chair, Istanbul University, Istanbul School of MedicineIrem Okcular, M.D., Study chair, Istanbul University, Istanbul School of MedicineYılmaz Nisanci, Prof., Study chair, Istanbul University, Istanbul School of MedicineBerrin Umman, Prof., Study chair, Istanbul University, Istanbul School of MedicineAhmet K Bilge, M.D., Study chair, Istanbul University, Istanbul School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302419
- Sponsor's protocol ID
- 5737
- Status last verified
- Jul 2008
- First submitted
- 13 Mar 2006
- Last updated
- 1 Aug 2008
- Results posted
- No
Publications
Sezer M, Cimen A, Aslanger E, Elitok A, Umman B, Bugra Z, Yormaz E, Turkmen C, Adalet IS, Nisanci Y, Umman S. Effect of intracoronary streptokinase administered immediately after primary percutaneous coronary intervention on long-term left ventricular infarct size, volumes, and function. J Am Coll Cardiol. 2009 Sep 15;54(12):1065-71. doi: 10.1016/j.jacc.2009.04.083.
PubMed 19744615Sezer M, Oflaz H, Goren T, Okcular I, Umman B, Nisanci Y, Bilge AK, Sanli Y, Meric M, Umman S. Intracoronary streptokinase after primary percutaneous coronary intervention. N Engl J Med. 2007 May 3;356(18):1823-34. doi: 10.1056/NEJMoa054374.
PubMed 17476008
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Complementary Intracoronary Streptokinase Administration Immediately After Primary Percutaneous Coronary Intervention on Microvascular Perfusion and Late Term Infarct Size in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00302419
- Acronym / sponsor ID
- 5737
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute myocardial infarction, primary angioplasty, streptokinase, microvasculature
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 14 Mar 2006 (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 investigators hypothesized that complementary intracoronary streptokinase administration to primary percutaneous intervention in patients with acute myocardial infarction may provide further improvement in myocardial perfusion by dissolving microvascular thrombus [in situ formed or embolized from proximal site (spontaneous or following PCI)] and fibrin.
Detailed description
Mechanical reperfusion for acute myocardial infarction (AMI) targets optimal revascularization of the epicardial artery but also aims at improved myocardial salvage. The goal of reperfusion therapies has shifted to include reperfusion downstream at the level of capillary bed, and it might be more appropriate that the hypothesis now be termed "the time dependent open artery and open microvascular hypothesis." Failure to achieve myocardial reperfusion despite the presence of a patent coronary artery has been termed the "no-reflow" phenomenon and attributed to microvascular dysfunction. It has become apparent that clinical outcomes are not only associated with patency of the epicardial artery, but also with patency of the microcirculation. Persistent impairment of microcirculation is associated with poor clinical outcome. Complete reperfusion in AMI settings necessitates reopening of the all consecutive vascular compartments all the way through the coronary circulation. But, embolization following percutaneous coronary intervention (PCI) and in situ microthrombi generation at the microvascular level makes this goal difficult to achieve. For this reason, mechanical intervention to the epicardial coronary artery with or without using distal protection wouldn't be enough to achieve ideal reperfusion at the ultimate (microvascular) level. At this point, it has become more evident that we need to develop more competent and feasible reperfusion strategies which can help us to achieve reperfusion as complete as possible at all levels.
Hypothesis:
Complementary intracoronary streptokinase administration to primary PCI may provide further improvement in myocardial perfusion by dissolving microvascular thrombus [in situ formed or embolized from proximal site (spontaneous or following PCI)] and fibrin. Improvement in microvascular perfusion may translate into reduction in infarct size and improvement in left ventricular function at long term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: intracoronary infusion,, Procedure: primary percutaneous coronary angioplastyFollowing standard primary percutaneous coronary intervention for ST elevation acute myocardial infarction 250.000 U intracoronary Streptokinase will be given |
| 2 | Active comparator | Procedure: primary percutaneous coronary angioplastyStandard percutaneous coronary intervention for ST elevation myocardial infarction will be performed |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Continuous chest pain that lasted > 30 minutes within the preceding 12 hours
- ST-segment elevation of at least 1 mm in 2 contiguous leads on the 12 leads ECG
- Infarct related artery (IRA) occlusion (TIMI grade 0) at the angiography
- Angiographically detected culprit coronary artery lesion deemed suitable for PCI
Key exclusion criteria (7 listed)
- Contraindications to streptokinase, tirofiban, aspirin, clopidogrel, or heparin
- Culprit lesion in saphenous vein graft
- TIMI grade II-III flow in IRA
- Additional epicardial stenosis in the IRA distal to stented segment (significant or insignificant)
- Presence of left bundle branch block
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 |
|---|---|---|
| intracoronary infusion,Also: Streptasestreptokinase, 250,000 units | Drug | 1 |
| primary percutaneous coronary angioplasty | Procedure or surgery | 1, 2 |
Primary outcome
Primary end points defined as the indices of the microvascular perfusion which is going to be assessed on day 2 (48 hours after the primary PCI)and infarct size at 6 months.
Time frame: 6 months
Index of microvascular resistance,
Time frame: 48 hours
Coronary flow reserve
Time frame: 48 hours
Left ventricular infarct size by SPECT at six months.
Time frame: 6 months
3 secondary outcomes
Death
Time frame: 1 year
Reinfarction
Time frame: 1 month
Major bleeding
Time frame: during hospitalization
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 1 Aug 2008.
- Derived from this study: PubMed 19744615Sezer M, Cimen A, Aslanger E, Elitok A, Umman B, Bugra Z, Yormaz E, Turkmen C, Adalet IS, Nisanci Y, Umman S. Effect of intracoronary streptokinase administered immediately after primary percutaneous coronary intervention on long-term left ventricular infarct size, volumes, and function. J Am Coll Cardiol. 2009 Sep 15;54(12):1065-71. doi: 10.1016/j.jacc.2009.04.083.
- Derived from this study: PubMed 17476008Sezer M, Oflaz H, Goren T, Okcular I, Umman B, Nisanci Y, Bilge AK, Sanli Y, Meric M, Umman S. Intracoronary streptokinase after primary percutaneous coronary intervention. N Engl J Med. 2007 May 3;356(18):1823-34. doi: 10.1056/NEJMoa054374.
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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.
Murat Sezer, M.D. study director
Istanbul University, Istanbul School of Medicine
Sabahattin Umman, Prof. principal investigator
Istanbul University, Istanbul School of Medicine
Taner Goren, Prof. study chair
Istanbul University, Istanbul School of Medicine
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 intracoronary infusion, and primary percutaneous coronary angioplasty in people with Acute Myocardial Infarction, run by Istanbul University 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 4 inclusion and 7 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 1 Aug 2008. 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?
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?
Primary end points defined as the indices of the microvascular perfusion which is going to be assessed on day 2 (48 hours after the primary PCI)and infarct size at 6 months. (time frame: 6 months). The study lists 4 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 NCT00302419, 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 1 Aug 2008.