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

June 30, 2021 updated by: Medstar Health Research Institute

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

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.

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who underwent primary Percutaneous Coronary Intervention at Washington Hospital Center since September 2000 and received eptifibatide pre-or during PCI or have received no eptifibatide.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Eptifibatide Pre PCI
Receive eptifibatide pre PCI
Eptifibatide during PCI
Receive eptifibatide during PCI
No Eptifibatide
Receive no eptifibatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality and composite or Q-wave myocardial infarction
Time Frame: 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.
Chart review 6 months after PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TIMI major bleeding
Time Frame: During hospital stay; average stay is less than 48 hours
Thrombolysis In Myocardial Infarction (TIMI) major bleeding during hospital stay.
During hospital stay; average stay is less than 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Investigators

  • Principal Investigator: Ron Waksman, MD, Medstar Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2013

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

November 18, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Integrilin Stemi

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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