Safety of TG100-115 for Heart Attack Treated With Angioplasty

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TargeGen

Criteria

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.