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NCT01991366 Clinical Trial

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

Acute Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01991366
Other study ID # Integrilin Stemi
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date October 2013
Est. completion date June 2021

Study information
Verified date June 2021
Source Medstar Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2021
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Washington Hospital Center Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause mortality and composite or Q-wave myocardial infarction 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 TIMI major bleeding Thrombolysis In Myocardial Infarction (TIMI) major bleeding during hospital stay. During hospital stay; average stay is less than 48 hours
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