Safety of TG100-115 for Heart Attack Treated With Angioplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-01-31

Brief Summary

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TG100-115 is able to reduce the size of heart attacks in pre-clinical models. The hypothesis of this study is that TG100-115 can be given safely to patients who suffer a heart attack and undergo angioplasty to restore blood flow. We will also evaluate whether TG100-115 reduces heart muscle damage.

Detailed Description

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Conditions

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Myocardial Infarction

Keywords

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myocardial infarction infarct size angioplasty percutaneous coronary intervention Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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TG100-115

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18-80 yrs
* ECG patterns consistent with an acute anterior myocardial infarction with ST segment elevation of 2mm in two contiguous ECG leads among leads V1-V4.
* Have prolonged, continuous (lasting at least 20 mins) signs and symptoms of myocardial ischemia not eliminated with nitrates.
* Intent to proceed to primary PCI within 6 hours of chest pain onset
* Sign an informed consent form and be willing to attend follow-up visits for safety and other study assessments.

Exclusion Criteria

* Female of childbearing potential.
* History of previous myocardial infarction.
* History of congestive heart failure.
* Requirement for a cardiac pacemaker or defibrillator.
* Cardiogenic shock.
* Patients previously treated with thrombolytic therapy.
* Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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David Holmes, MD

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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TG001-03

Identifier Type: -

Identifier Source: org_study_id

NCT00104208