Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety of TG100-115 for Heart Attack Treated With Angioplasty

This study has been completed.
Sponsor:
Information provided by:
TargeGen
ClinicalTrials.gov Identifier:
NCT00103350
First received: February 7, 2005
Last updated: May 16, 2008
Last verified: May 2008

February 7, 2005
May 16, 2008
January 2005
December 2006   (final data collection date for primary outcome measure)
Safety and pharmacokinetics of TG100-115
Same as current
Complete list of historical versions of study NCT00103350 on ClinicalTrials.gov Archive Site
Impact of TG100-115 on infarct size
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Myocardial Infarction
Drug: TG100-115
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2008
December 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00103350
TG001-03
Not Provided
Not Provided
TargeGen
Not Provided
Not Provided
TargeGen
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP