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NCT02603835 · ClinicalTrials.gov registry record · NA

Evaluation of Intracoronary Hyperoxemic Oxygen Therapy in Anterior Acute Myocardial Infarction Patients (IC-HOT)

A NA study, sponsored by TherOx.

Completed
Registry status
NA
Development phase
100
Enrollment target

NCT02603835: Completed NA study, sponsored by TherOx.

NCT02603835 is a NA study that has completed, run by TherOx. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02603835, a NA study, has completed, sponsored by TherOx.

COMPLETED
Registry status
NA
Development phase
100 participants
Enrollment target

Study Summary

The primary objective of the study is to collect confirmatory data supporting the safety and effectiveness of SSO2 Therapy in treatment of anterior acute myocardial infarction (AMI) patients who have undergone successful percutaneous coronary intervention (PCI) with stenting within six hours of experiencing AMI symptoms.

Primary Outcome

Composite of death, reinfarction, clinically-driven target vessel revascularization, stent thrombosis (ARC definite or probable), new onset severe heart failure or readmission for heart failure, and TIMI major or minor bleeding. This outcome measure includes a hierarchical sum of the events, meaning if a subject experiences two event types they are only counted once in the overall NACE rate.

Interventions

  • DEVICE SSO2 Therapy

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2016-02
Est. Completion 2018-05-17
Phase NA
TherOx

6 total trials

What the finished NCT02603835 record still lists

NCT02603835 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 1 intervention - of which SSO2 Therapy is the first listed.

NCT02603835 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02603835 about?

NCT02603835 is a clinical study titled "Evaluation of Intracoronary Hyperoxemic Oxygen Therapy in Anterior Acute Myocardial Infarction Patients (IC-HOT)". The primary objective of the study is to collect confirmatory data supporting the safety and effectiveness of SSO2 Therapy in treatment of anterior acute myocardial infarction (AMI) patients who have undergone successful percutaneous coronary intervention (PCI) with stenting within six hours of expe...

What is the current status of trial NCT02603835?

This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2016-02. Estimated completion is 2018-05-17.

What interventions are being tested in trial NCT02603835?

The interventions under investigation include: SSO2 Therapy (DEVICE).

Who is sponsoring clinical trial NCT02603835?

This trial is sponsored by TherOx, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02603835's enrollment target sits among peer trials

100 840th of 2000 higher than 1,081 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02603835, the US trial registry maintained by the National Library of Medicine. NCT02603835 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.