Intracoronary Integrilin Administration in Patient with Acute ST-Elevation Myocardial Infarction undergoing Primary PCI

Not Applicable

• Conditions: Condition 1: Acute myocardial infarction. Condition 2: Recurrent Myocardial Infarction.; Acute myocardial infarction; Subsequent myocardial infarction

• Registration Number: IRCT2012090510751N1
• Lead Sponsor: QUMS Deputy for Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Inclusion Criteria: an acute coronary syndrome with the indication for cardiac catheterization being ST-elevation myocardial infarction; coronary artery disease with a visually estimated stenosis of at least 75% in at least 1 epicardial vessel suitable for stenting; age 18 years; negative pregnancy test in women of childbearing potential; informed consent for participation in the trial

Exclusion Criteria

multivessel PCI at the time of the index procedure or planned PCI within 30 days of the index procedure; severe coronary calcification; unprotected left main stenosis > 50%; target lesion in a saphenous vein graft; acute ST-elevation myocardial infarction after a primary PCI strategy; previous stenting at the target lesion; target lesion in an occluded vessel; deep vein thrombosis; presence of an inferior vena cava filter; a contraindication to GP IIb/IIIa inhibitor therapy (Hypersensitivity to eptifibatide or any component of the product; active abnormal bleeding within the previous 30 days or a history of bleeding diathesis; history of stroke within 30 days or a history of hemorrhagic stroke; severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) not adequately controlled on antihypertensive therapy; major surgery within the preceding 6 weeks; current or planned administration of another parenteral GP IIb/IIIa inhibitor; dependency on hemodialysis).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TIMI Flow Grade. Timepoint: Before and After Primary PCI. Method of measurement: Antrograde Coronary Perfusion assessed by Coronary Angiograpgy.;TIMI Perfusion Grade. Timepoint: Before and After Primary PCI. Method of measurement: Antrograde Coronary Perfusion assessed by Coronary Angiograpgy based on TPG classification.;TIMI Frame Count. Timepoint: Before and After Primary PCI. Method of measurement: Angioraphic frame count of contrast from injection to filling the coronary artery which underwent Primary PCI.

Secondary Outcome Measures

Name	Time	Method
Adverse Bleeding Event. Timepoint: From Primary PCI to Patient Discharge. Method of measurement: Incidence of Bleeding event during hospitalization based on International Bleeding classification.;Change in Ejection Fraction. Timepoint: Before Primary PCI and 5 days after. Method of measurement: By Echocardiography.;ST Segment Elevation Resolution. Timepoint: Before Primary PCI and 60 minutes after. Method of measurement: Single-lead ST elevation (ST-E) recovery (percent reduction in ST-E from baseline to post-PCI ECG in the lead with maximum baseline ST-E).;Thrombocytopenia. Timepoint: Before Primary PCI and 3 hours after. Method of measurement: Reduction of Platelet in PBS over 50% or below 100000 per ml.