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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00627809

Enrollment

Registered

2008-03-03

Start date

2007-01-31

Completion date

2008-02-29

Last updated

2009-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndromes, Acute Myocardial Infarction, Reperfusion Injury

Keywords

coronary microcirculation, acut myocardial infarction, infarct size, streptokinase, reperfusion

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).

Interventions

DRUGStreptokinase

intracoronary infusion, 250.000 Units

PROCEDUREprimary percutaneous coronary intervention

balloon catheter, stent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Reinfarction	from recruitment until the last follow-up at 5-6 months
Major bleeding	from recruitment to discharge
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.	early phase (at discharge) and late phase (5-6 months)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026