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

NCT00302419 | Completed Phase 4

• 1 other identifier: 5737
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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 \[in situ formed or embolized from proximal site (spontaneous or following PCI)\] and fibrin.

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarction; primary angioplasty; streptokinase; microvasculature

Outcome Measures

Primary Outcomes (4)

• 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.

  6 months

• Index of microvascular resistance,

  48 hours

• Coronary flow reserve

  48 hours

• Left ventricular infarct size by SPECT at six months.

  6 months

Secondary Outcomes (3)

• Death

  1 year

• Reinfarction

  1 month

• Major bleeding

  during hospitalization

Study Arms (2)

1

EXPERIMENTAL

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

Drug: intracoronary infusion,; Procedure: primary percutaneous coronary angioplasty

2

ACTIVE COMPARATOR

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

Procedure: primary percutaneous coronary angioplasty

Interventions

intracoronary infusion, DRUG

streptokinase, 250,000 units

Also known as: Streptase

1

primary percutaneous coronary angioplasty PROCEDURE

1; 2

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Istanbul School of Medicine, Department of Cardiology

Istanbul, 34290, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 19744615 DERIVED

• 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.

  PMID: 17476008 DERIVED

MeSH Terms

Interventions

Streptokinase

Intervention Hierarchy (Ancestors)

Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Murat Sezer, M.D.

  Istanbul University, Istanbul School of Medicine

  STUDY DIRECTOR

• Sabahattin Umman, Prof.

  Istanbul University, Istanbul School of Medicine

  PRINCIPAL INVESTIGATOR

• Taner Goren, Prof.

  Istanbul University, Istanbul School of Medicine

  STUDY CHAIR

• Huseyin Oflaz, Assoc.Prof.

  Istanbul University, Istanbul School of Medicine

  STUDY CHAIR

• Irem Okcular, M.D.

  Istanbul University, Istanbul School of Medicine

  STUDY CHAIR

• Yılmaz Nisanci, Prof.

  Istanbul University, Istanbul School of Medicine

  STUDY CHAIR

• Berrin Umman, Prof.

  Istanbul University, Istanbul School of Medicine

  STUDY CHAIR

• Ahmet K Bilge, M.D.

  Istanbul University, Istanbul School of Medicine

  STUDY CHAIR

• Mehmet Meric, Prof.

  Istanbul University, Istanbul School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 13, 2006
• First Posted: March 14, 2006
• Study Start: October 1, 2004
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2008
• Last Updated: August 1, 2008

Record last verified: 2008-07

Locations

TU (1)