Overview

This trial is active, not recruiting.

Conditions st-elevation myocardial infarction, acute myocardial infarction
Sponsor Medstar Research Institute
Start date October 2013
End date October 2014
Trial size 800 participants
Trial identifier NCT01991366, Integrilin Stemi

Summary

The aim of this observational study is to evaluate the in hospital and 6 month outcomes of the use of Glycoprotein IIb/IIIa inhibitor eptifibatide as adjunctive therapy in patients undergoing primary Percutaneous Coronary Intervention for ST-elevation myocardial infarction in a large tertiary referral center.

It is hypothesized that Glycoprotein IIb/IIIa inhibitor use during primary Percutaneous Coronary Intervention for ST-elevation myocardial infarction/ acute myocardial infarction is superior to unfractionated heparin alone or bivalirudin alone. Additionally, after propensity matching this superiority remains.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective retrospective
Arm
Receive eptifibatide pre PCI
Receive eptifibatide during PCI
Receive no eptifibatide

Primary Outcomes

Measure
All-cause mortality and composite or Q-wave myocardial infarction
time frame: Chart review 6 months after PCI

Secondary Outcomes

Measure
TIMI major bleeding
time frame: During hospital stay; average stay is less than 48 hours

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Underwent Percutaneous Coronary Intervention at Washington Hospital Center since September 2000 - Either received eptifibatide pre-or during PCI or have received no eptifibatide. Exclusion Criteria: - Patients who received a thrombolytic prior to Percutaneous Coronary Intervention.

Additional Information

Official title Should Integrilin be an Integral Part of Adjunctive Therapy in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction?
Principal investigator Ron Waksman, MD
Description This is a retrospective, observational, data analysis of approximately 800 patients who underwent primary Percutaneous Coronary Intervention at our institution since September 2000. Patients will have either received eptifibatide pre-or during Percutaneous Coronary Intervention or have received no eptifibatide. Patients who received a thrombolytic prior to Percutaneous Coronary Intervention will be excluded. This analysis is estimated to take 1-2 months.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Medstar Research Institute.