Safety of TG100-115 for Heart Attack Treated With Angioplasty

TargeGen

Status and phase

Completed

Phase 2

Phase 1

Conditions

Myocardial Infarction

Treatments

Drug: TG100-115

Study type

Interventional

Funder types

Industry

Identifiers

NCT00103350

TG001-03

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.