Acute Coronary SyndromesPhase 4NCT00627809

Effect of Adjunctive Intracoronary Streptokinase on Late Term Left Ventricular Infarct Size and Volumes in Patients With Acute Myocardial Infarction

A Phase 4 study testing Streptokinase and primary percutaneous coronary intervention in people with Acute Coronary Syndromes and Acute Myocardial Infarction, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators hypothesized that complementary intracoronary streptokinase administration to primary percutaneous intervention in patients with acute myocardial infarction may provide limitation infarct size and improvement in left ventricular volumes and function in acute and late phases (6 months). Read more about this study

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Acute Coronary Syndromes, Acute Myocardial Infarction, Reperfusion Injury
What is being tested?: Streptokinase and primary percutaneous coronary intervention
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Jan 2007to 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 ECG
Infarct related artery (IRA) occlusion (TIMI grade 0) at the angiography

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Istanbul, 34290

Other trials in Turkey (Türkiye)

About this study

Official title: Phase 4 Study of Application of Intracoronary Low Dose Streptokinase Complementary to Standard Percutaneous Coronary Intervention in Patients With ST Elevation Acute Myocardial Infarction: Effect of Adjunctive Intracoronary Streptokinase on Late Term Left Ventricular Infarct Size and Volumes in Patients With Acute Myocardial Infarction

Conditions: Acute Coronary Syndromes, Acute Myocardial Infarction, Reperfusion Injury
Being tested: Streptokinase, primary percutaneous coronary intervention
Keywords: coronary microcirculation, acut myocardial infarction, infarct size, streptokinase, reperfusion
Medical subject headings: Acute Coronary Syndrome, Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

StreptokinaseDrug
Also called Streptase (Streptokinase)
intracoronary infusion, 250.000 Units
primary percutaneous coronary interventionProcedure or surgery
balloon catheter, stent

Study groups in NCT00627809
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: Streptokinase; Procedure: primary percutaneous coronary intervention
2	Active comparator	Standard percutaneous coronary intervention for ST elevation myocardial infarction will be performed Receives: Procedure: primary percutaneous coronary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Left ventricular infarct size by SPECT
Measured: at long term (5-6 months)
Left ventricular diastolic volume
Measured: at long term (5-6 months)
Left ventricular systolic volume
Measured: at long term (5-6 months)
Left ventricular ejection fraction
Measured: at long term (5-6 months)

Secondary outcomes (3)

Temporal changes (from baseline to 5 months follow-up) in microvascular perfusion indices (index of microvascular resistance, coronary flow reserve) and in infarct size have been interrogated in only control group.
Measured: early phase (at discharge) and late phase (5-6 months)
Reinfarction
Measured: from recruitment until the last follow-up at 5-6 months
Major bleeding
Measured: from recruitment to discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Feb 2008

First posted3 Mar 2008 (estimated)
Study startJan 2007
Primary completionJan 2008
Study completionFeb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute Coronary SyndromesStudies 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: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00627809
Sponsor's protocol ID: 2007-337
Status last verified: Jun 2009
First submitted: 22 Feb 2008
Last updated: 23 Jun 2009
Results posted: No
Data monitoring committee: No

Publications

Sezer 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Coronary Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 4 Study of Application of Intracoronary Low Dose Streptokinase Complementary to Standard Percutaneous Coronary Intervention in Patients With ST Elevation Acute Myocardial Infarction: Effect of Adjunctive Intracoronary Streptokinase on Late Term Left Ventricular Infarct Size and Volumes in Patients With Acute Myocardial Infarction
ClinicalTrials.gov ID: NCT00627809
Acronym / sponsor ID: 2007-337
Conditions: Acute Coronary Syndromes, Acute Myocardial Infarction, Reperfusion Injury
Keywords: coronary microcirculation, acut myocardial infarction, infarct size, streptokinase, reperfusion
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Istanbul UniversityUniversity, hospital or other
Study start: Jan 2007
Primary completion: Jan 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 3 Mar 2008 (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.

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: Streptokinase, Procedure: primary percutaneous coronary interventionFollowing 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 interventionStandard 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 (3 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 ECG
Infarct related artery (IRA) occlusion (TIMI grade 0) at the angiography

Key exclusion criteria (6 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
StreptokinaseAlso: Streptase (Streptokinase)intracoronary infusion, 250.000 Units	Drug	1
primary percutaneous coronary interventionballoon catheter, stent	Procedure or surgery	1, 2

Primary outcome

Left ventricular infarct size by SPECT
Time frame: at long term (5-6 months)
Left ventricular diastolic volume
Time frame: at long term (5-6 months)
Left ventricular systolic volume
Time frame: at long term (5-6 months)
Left ventricular ejection fraction
Time frame: at long term (5-6 months)

3 secondary outcomes

Temporal changes (from baseline to 5 months follow-up) in microvascular perfusion indices (index of microvascular resistance, coronary flow reserve) and in infarct size have been interrogated in only control group.
Time frame: early phase (at discharge) and late phase (5-6 months)
Reinfarction
Time frame: from recruitment until the last follow-up at 5-6 months
Major bleeding
Time frame: from recruitment to discharge

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 23 Jun 2009.
Background: 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.

Related trials for Acute Coronary Syndromes

Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease

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, Assoc. Prof. principal investigator

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Sabahattin Umman, Prof. study director

Istanbul University,Istanbul Faculty of Medicine, Department of Cardiology

Arif O Cimen, M.D. study chair

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 6 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 23 Jun 2009. 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?

Left ventricular infarct size by SPECT (time frame: at long term (5-6 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 NCT00627809, which also lists 1 linked publication.

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 23 Jun 2009.