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CompletedNCT00103350Updated May 20, 2008

Safety of TG100-115 for Heart Attack Treated With Angioplasty

A Phase 1/2 interventional study of TG100-115 in Myocardial Infarction, sponsored by TargeGen. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-05-20.

Sponsored by TargeGen · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myocardial Infarction

Keywords

  • myocardial infarction
  • infarct size
  • angioplasty
  • percutaneous coronary intervention
  • Acute Myocardial Infarction
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 100 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

TargeGen is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
100 participants

Interventions

  • DrugTG100-115
06

What researchers measure

Primary outcomes

  1. Safety and pharmacokinetics of TG100-115

Secondary outcomes

  1. Impact of TG100-115 on infarct size

07

Study locations

1 site
  • David Holmes, MD
    Rochester, Minnesota 55905, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00103350
Lead sponsor
TargeGen
First posted
Feb 8, 2005
Start date
Jan 2005
Primary completion
Dec 2006
Completion
Jan 2008
Last update
May 20, 2008
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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