Should Integrilin be an Integral Part of Adjunctive Therapy in Patients Undergoing Primary PCI for ST-Elevation MI?
|ClinicalTrials.gov Identifier: NCT01991366|
Recruitment Status : Unknown
Verified August 2014 by Medstar Health Research Institute.
Recruitment status was: Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : August 11, 2014
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.
|Condition or disease|
|ST-elevation Myocardial Infarction Acute Myocardial Infarction|
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|
|Estimated Enrollment :||800 participants|
|Observational Model:||Case Control|
|Official Title:||Should Integrilin be an Integral Part of Adjunctive Therapy in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction?|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||October 2014|
Eptifibatide Pre PCI
Receive eptifibatide pre PCI
Eptifibatide during PCI
Receive eptifibatide during PCI
Receive no eptifibatide
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991366
|United States, District of Columbia|
|Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Ron Waksman, MD||Medstar Health Research Institute|