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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01991366

Enrollment

Registered

2013-11-25

Start date

2013-10-31

Completion date

2021-06-30

Last updated

2021-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, ST-elevation Myocardial Infarction

Keywords

Major adverse microvascular integrity, all cause mortality, Q Wave MI

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Exclusion criteria

* Patients who received a thrombolytic prior to Percutaneous Coronary Intervention.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results