Should Integrilin be an Integral Part of Adjunctive Therapy in Patients Undergoing Primary PCI for ST-Elevation MI?

Sponsor

Medstar Health Research Institute (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01991366

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
ST-elevation Myocardial Infarction Acute Myocardial Infarction

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Should Integrilin be an Integral Part of Adjunctive Therapy in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction?

Anticipated Study Start Date :

Oct 1, 2013

Anticipated Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Eptifibatide Pre PCI Receive eptifibatide pre PCI
Eptifibatide during PCI Receive eptifibatide during PCI
No Eptifibatide Receive no eptifibatide

Outcome Measures

Primary Outcome Measures

All-cause mortality and composite or Q-wave myocardial infarction [Chart review 6 months after PCI]
6-month rates of all-cause mortality and the composite of all-cause mortality or Q-wave myocardial infarction.

Secondary Outcome Measures

TIMI major bleeding [During hospital stay; average stay is less than 48 hours]
Thrombolysis In Myocardial Infarction (TIMI) major bleeding during hospital stay.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.