Should Integrilin be an Integral Part of Adjunctive Therapy in Patients Undergoing Primary PCI for ST-Elevation MI?
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|