Safety of TG100-115 for Heart Attack Treated With Angioplasty

TargeGen100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Myocardial Infarction

Interventions

TG100-115DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

David Holmes, MD

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Safety and pharmacokinetics of TG100-115

Secondary Outcomes

Impact of TG100-115 on infarct size

Data from ClinicalTrials.gov

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