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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-elevation Myocardial Infarction

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