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

Withdrawn

• Conditions: ST-elevation Myocardial Infarction; Acute Myocardial Infarction

• Registration Number: NCT01991366
• Lead Sponsor: Medstar Health Research Institute

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.

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Primary Completion: 2014-10
• Status Verified: 2021-06
• Study Completion: 2021-06
• Last Update Submitted: 2021-06-30
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States