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

This study has been completed.

Sponsor:

Information provided by:

Istanbul University

ClinicalTrials.gov Identifier:

NCT00627809

First received: February 22, 2008

Last updated: June 22, 2009

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 22, 2008

Last Updated Date

June 22, 2009

Start Date ^ICMJE

January 2007

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Left ventricular infarct size by SPECT [ Time Frame: at long term (5-6 months) ] [ Designated as safety issue: No ]
Left ventricular diastolic volume [ Time Frame: at long term (5-6 months) ] [ Designated as safety issue: No ]
Left ventricular systolic volume [ Time Frame: at long term (5-6 months) ] [ Designated as safety issue: No ]
Left ventricular ejection fraction [ Time Frame: at long term (5-6 months) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00627809 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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) ] [ Designated as safety issue: No ]
Reinfarction [ Time Frame: from recruitment until the last follow-up at 5-6 months ] [ Designated as safety issue: Yes ]
Major bleeding [ Time Frame: from recruitment to discharge ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Differences between changes in microvascular perfusion indices (index of microvascular resistance, coronary flow reserve) in two groups. [ Time Frame: early phase (at discharge) and late phase (5-6 months) ] [ Designated as safety issue: No ]
Coronary microvascular perfusion (index of microvascular resistance, coronary flow reserve) [ Time Frame: at long term (5-6 months) ] [ Designated as safety issue: No ]
Reinfarction [ Time Frame: from recruitment until the last follow-up at 5-6 months ] [ Designated as safety issue: Yes ]
Major bleeding [ Time Frame: from recruitment to discharge ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Acute Coronary Syndromes
Acute Myocardial Infarction
Reperfusion Injury

Intervention ^ICMJE

Drug: Streptokinase
intracoronary infusion, 250.000 Units

Other Name: Streptase (Streptokinase)
Procedure: primary percutaneous coronary intervention
balloon catheter, stent

Study Arm (s)

Experimental: 1
Following standard primary percutaneous coronary intervention for ST elevation acute myocardial infarction 250.000 U intracoronary Streptokinase will be given
Interventions:
- Drug: Streptokinase
- Procedure: primary percutaneous coronary intervention
Active Comparator: 2
Standard percutaneous coronary intervention for ST elevation myocardial infarction will be performed

Intervention: Procedure: primary percutaneous coronary intervention

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Turkey

Administrative Information

NCT Number ^ICMJE

NCT00627809

Other Study ID Numbers ^ICMJE

2007-337

Has Data Monitoring Committee

Responsible Party

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

Study Sponsor ^ICMJE

Istanbul University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Murat Sezer, Assoc. Prof.	Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Study Director:	Sabahattin Umman, Prof.	Istanbul University,Istanbul Faculty of Medicine, Department of Cardiology
Study Chair:	Arif O Cimen, M.D.	Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Study Chair:	Emre K Aslanger, M.D.	Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Study Chair:	Berrin Umman, Prof.	Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Study Chair:	Zehra Bugra, Prof.	Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Study Chair:	Isik Adalet, Prof.	Istanbul University, Istanbul Faculty of Medicine, Department of Nuclear Medicine
Study Chair:	Cuneyt Turkmen, Assoc. Prof.	Istanbul University, Istanbul Faculty of Medicine, Department of Nuclear Medicine

Information Provided By

Istanbul University

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top