Trial | NCT00103350  Report issue

Title

Safety of TG100-115 for Heart Attack Treated With Angioplasty
A Phase 1-2, Multicenter, Randomized, Double-Blind, Placebo Controlled, Prospective Study to Evaluate the Safety and Potential Efficacy of Single, Increasing Doses of TG100-115 in Subjects Undergoing Percutaneous Coronary Intervention for Acute Anterior ST Elevation Myocardial Infarction

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tg100 ...

  • Study Participants

    100
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 Started
Jan 31
2005
Primary Completion
Dec 31
2006
Study Completion
Jan 31
2008
Last Update
May 20
2008
Estimate

Drug TG100-115

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.
No Results Posted