Should Integrilin be an Integral Part of Adjunctive Thera... | NCT01991366

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

NCT01991366

Sponsor

Medstar Health Research Institute

Status

Withdrawn

Last Update Posted

Jul 2, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

ST-elevation Myocardial Infarction
Acute Myocardial Infarction

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of funding

Expanded Access Info

Start Date

Oct 2013Estimated

Primary Completion Date

Oct 2014Estimated

Completion Date

Jun 2021Actual

First Submitted Date

Nov 18, 2013

First Submission Date that Met QC Criteria

Nov 18, 2013

First Posted Date

Nov 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2021

Last Update Posted Date

Jul 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eptifibatide Pre PCI		Receive eptifibatide pre PCI
Eptifibatide during PCI		Receive eptifibatide during PCI
No Eptifibatide		Receive no eptifibatide

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
TIMI major bleeding	Thrombolysis In Myocardial Infarction (TIMI) major bleeding during hospital stay.	During hospital stay; average stay is less than 48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ron Waksman, MD	Medstar Health Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington Hospital Center		Washington D.C.	District of Columbia	20010	United States

Condition Browse Module

MeSH Terms

ID	Term
D000072657	ST Elevation Myocardial Infarction

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided