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

February 22, 2008
June 22, 2009
January 2007
January 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00627809 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Effect of Adjunctive Intracoronary Streptokinase on Late Term Left Ventricular Infarct Size and Volumes in Patients With Acute Myocardial Infarction
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

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Coronary Syndromes
  • Acute Myocardial Infarction
  • Reperfusion Injury
  • Drug: Streptokinase
    intracoronary infusion, 250.000 Units
    Other Name: Streptase (Streptokinase)
  • Procedure: primary percutaneous coronary intervention
    balloon catheter, stent
  • 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
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.
 
Completed
53
February 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00627809
2007-337
No
Istanbul University, Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Istanbul University
Not Provided
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
Istanbul University
June 2009

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