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

NCT01991366 | Withdrawn

• 1 other identifier: Integrilin Stemi
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

ST-elevation Myocardial Infarction; Acute Myocardial Infarction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• TIMI major bleeding

  During hospital stay; average stay is less than 48 hours

Study Arms (3)

Eptifibatide Pre PCI

Receive eptifibatide pre PCI

Eptifibatide during PCI

Receive eptifibatide during PCI

No Eptifibatide

Receive no eptifibatide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who underwent primary Percutaneous Coronary Intervention at Washington Hospital Center since September 2000 and received eptifibatide pre-or during PCI or have received no eptifibatide.

You may qualify if:

• Underwent Percutaneous Coronary Intervention at Washington Hospital Center since September 2000
• Either received eptifibatide pre-or during PCI or have received no eptifibatide.

You may not qualify if:

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

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Ron Waksman, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 25, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: June 1, 2021
• Last Updated: July 2, 2021

Record last verified: 2021-06

Locations

US (1)