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Safety of TG100-115 for Heart Attack Treated with Angioplasty - Article


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Heart Attack

Acute Myocardial Infraction; Myocardial Infarction


Clinical Trial: Safety of TG100-115 for Heart Attack Treated with Angioplasty

This study is currently recruiting patients.

Sponsored by: TargeGen
Information provided by: TargeGen

Purpose

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 Treatment or Intervention Phase
Myocardial Infarction
 Drug: TG100-115
Phase I
Phase II

MedlinePlus related topics:  Heart Attack

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: Safety and pharmacokinetics of TG100-115
Secondary Outcomes: Impact of TG100-115 on infarct size
Expected Total Enrollment:  100

Study start: January 2005

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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.

Location and Contact Information

Charles P Theuer, MD PhD      858 964-2167    theuer@targegen.com
Jolene Shorr      858 964-2166    shorr@targegen.com

Minnesota
      David Holmes, MD, Rochester,  Minnesota,  55905,  United States; Recruiting

More Information

Study ID Numbers:  TG001-03
Record last reviewed:  February 2005
Last Updated:  February 7, 2005
Record first received:  February 7, 2005
ClinicalTrials.gov Identifier:  NCT00103350
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: May 11, 2006
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