Safety of TG100-115 for Heart Attack Treated With Angioplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00103350
Recruitment Status : Completed
First Posted : February 8, 2005
Last Update Posted : May 20, 2008
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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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: TG100-115 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Safety and pharmacokinetics of TG100-115

Secondary Outcome Measures :
  1. Impact of TG100-115 on infarct size

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00103350

United States, Minnesota
David Holmes, MD
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
TargeGen Identifier: NCT00103350     History of Changes
Obsolete Identifiers: NCT00104208
Other Study ID Numbers: TG001-03
First Posted: February 8, 2005    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008

Keywords provided by TargeGen:
myocardial infarction
infarct size
percutaneous coronary intervention
Acute Myocardial Infarction

Additional relevant MeSH terms:
Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases