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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00103350

Enrollment

100

Registered

2005-02-08

Start date

2005-01-31

Completion date

2008-01-31

Last updated

2008-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

myocardial infarction, infarct size, angioplasty, percutaneous coronary intervention, Acute Myocardial Infarction

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.

Interventions

DRUGTG100-115

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
Safety and pharmacokinetics of TG100-115	—

Secondary

Measure	Time frame
Impact of TG100-115 on infarct size	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026