Safety of TG100-115 for Heart Attack Treated With Angioplasty
Phase 1
Completed
- Conditions
- Myocardial Infarction
- Registration Number
- NCT00103350
- Lead Sponsor
- TargeGen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety and pharmacokinetics of TG100-115
- Secondary Outcome Measures
Name Time Method Impact of TG100-115 on infarct size
Trial Locations
- Locations (1)
David Holmes, MD
🇺🇸Rochester, Minnesota, United States