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

NCT ID: NCT00627809

Last Updated: 2009-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-02-29

Brief Summary

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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).

Detailed Description

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Conditions

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Acute Coronary Syndromes Acute Myocardial Infarction Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

Following standard primary percutaneous coronary intervention for ST elevation acute myocardial infarction 250.000 U intracoronary Streptokinase will be given

Group Type EXPERIMENTAL

Streptokinase

Intervention Type DRUG

intracoronary infusion, 250.000 Units

primary percutaneous coronary intervention

Intervention Type PROCEDURE

balloon catheter, stent

2

Standard percutaneous coronary intervention for ST elevation myocardial infarction will be performed

Group Type ACTIVE_COMPARATOR

primary percutaneous coronary intervention

Intervention Type PROCEDURE

balloon catheter, stent

Interventions

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Streptokinase

intracoronary infusion, 250.000 Units

Intervention Type DRUG

primary percutaneous coronary intervention

balloon catheter, stent

Intervention Type PROCEDURE

Other Intervention Names

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Streptase (Streptokinase)

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Principal Investigators

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Murat Sezer, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Sabahattin Umman, Prof.

Role: STUDY_DIRECTOR

Istanbul University,Istanbul Faculty of Medicine, Department of Cardiology

Arif O Cimen, M.D.

Role: STUDY_CHAIR

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Emre K Aslanger, M.D.

Role: STUDY_CHAIR

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Berrin Umman, Prof.

Role: STUDY_CHAIR

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Zehra Bugra, Prof.

Role: STUDY_CHAIR

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Isik Adalet, Prof.

Role: STUDY_CHAIR

Istanbul University, Istanbul Faculty of Medicine, Department of Nuclear Medicine

Cuneyt Turkmen, Assoc. Prof.

Role: STUDY_CHAIR

Istanbul University, Istanbul Faculty of Medicine, Department of Nuclear Medicine

Locations

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Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 17476008 (View on PubMed)

Other Identifiers

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2007-337

Identifier Type: -

Identifier Source: org_study_id

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