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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01991366
First received: November 18, 2013
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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
ST-elevation Myocardial Infarction
Acute Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Should Integrilin be an Integral Part of Adjunctive Therapy in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction?

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • All-cause mortality and composite or Q-wave myocardial infarction [ Time Frame: Chart review 6 months after PCI ] [ Designated as safety issue: No ]
    6-month rates of all-cause mortality and the composite of all-cause mortality or Q-wave myocardial infarction.


Secondary Outcome Measures:
  • TIMI major bleeding [ Time Frame: During hospital stay; average stay is less than 48 hours ] [ Designated as safety issue: No ]
    Thrombolysis In Myocardial Infarction (TIMI) major bleeding during hospital stay.


Estimated Enrollment: 800
Study Start Date: October 2013
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Eptifibatide Pre PCI
Receive eptifibatide pre PCI
Eptifibatide during PCI
Receive eptifibatide during PCI
No Eptifibatide
Receive no eptifibatide

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01991366

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Research Institute
Investigators
Principal Investigator: Ron Waksman, MD Medstar Research Institute
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01991366     History of Changes
Other Study ID Numbers: Integrilin Stemi
Study First Received: November 18, 2013
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medstar Research Institute:
Major adverse microvascular integrity
all cause mortality
Q Wave MI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Eptifibatide
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014