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Eptifibatide facilitated PCI

Phase 3

Myocardial Infarction | Small molecule | Cardiovascular |Medtronic plc.|Last Updated: Sep 4, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment400

FDA Designations

No designations recorded

Clinical trial landscape

Eptifibatide facilitated PCI · 1 trial · 1 indication

Phase 3 1
NCT00251823Safety and Efficacy Study of Eptifibatide in Primary Percutaneous Coronary Intervention (PCI)Myocardial Infarction
COMPLETED400 Analytics
PHASE3COMPLETED
Safety and Efficacy Study of Eptifibatide in Primary Percutaneous Coronary Intervention (PCI)
Myocardial InfarctionUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary clinical endpoint is a composite measure of clinical outcomes of death, recurrent myocardial infarction, and recurrent severe ischemia, which will be assessed at 30 days after the index acute myocardial infarction (AMI)

Secondary Endpoints

Determine if a facilitated PCI strategy with early initiation of eptifibatide improves the percentage of patients with TIMI grade 3 flow measured at the time of baseline angiography
improves post procedural TIMI perfusion scoreC
improves ST-segment elevation resolution, a surrogate marker of clinical efficacy
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Eptifibatide facilitated PCIDRUG -
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Eligibility Criteria

SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Ischemic chest discomfort of 30 minutes duration * Onset of chest pain 12 hours prior to entry into the study * ST segment elevation of \> 1 mm (0.1 mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead electrocardiogram \[ECG\]), or left bundle branc...

Countries:Canada
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Frequently asked questions about Eptifibatide facilitated PCI

What is Eptifibatide facilitated PCI used for?

Eptifibatide facilitated PCI is used for the treatment of myocardial infarction, commonly known as a heart attack. It is administered in the context of primary percutaneous coronary intervention, a procedure to open blocked coronary arteries. The drug is being studied to evaluate its safety and efficacy in this setting.

Who makes Eptifibatide facilitated PCI?

Eptifibatide facilitated PCI is developed by Medtronic plc, a medical technology company. Medtronic is publicly traded on the New York Stock Exchange under the ticker symbol MDT. The company is conducting clinical research to evaluate this treatment for myocardial infarction.

What phase is Eptifibatide facilitated PCI in?

Eptifibatide facilitated PCI is in Phase 3 clinical development. It is an investigational therapy for myocardial infarction and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under evaluation for its safety and efficacy.

What clinical trials is Eptifibatide facilitated PCI in?

Eptifibatide facilitated PCI has one completed Phase 3 clinical trial registered under NCT00251823. The trial, titled "Safety and Efficacy Study of Eptifibatide in Primary Percutaneous Coronary Intervention (PCI)," enrolled 400 participants with myocardial infarction in Canada. The study was not blinded and did not use a control group.

Is Eptifibatide facilitated PCI a randomized trial?

The Phase 3 clinical trial of Eptifibatide facilitated PCI was randomized, meaning participants were assigned to treatment groups by chance. However, the trial was not double-blind and did not use a control group. The study enrolled 400 participants and has been completed.